Multi-fluid medical injector system and methods of operation

ABSTRACT

A multi-fluid injector system and methods of operation thereof are presented. One embodiment of such a fluid injector system includes an automatic refill procedure for a fluid injector system comprising a fluid injector and an operably engaged syringe. The procedure includes the step of determining, using an electronic control device operably controlling the fluid injector system, whether a fluid injection procedure involving the syringe is impending. If the electronic control device determines that the fluid injection procedure is not impending, such that the automatic refill will not interfere with the fluid injection procedure, an automatic refill of the syringe is initiated.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a divisional of U.S. application Ser. No.13/386,765, filed Jan. 24, 2012, “Multi-Fluid Medical Injector Systemand Methods of Operation”, now U.S. Pat. No. 8,945,051, which is anational phase of International Patent Application No.PCT/US2010/042501, filed Jul. 20, 2010, entitled “Multi-Fluid MedicalInjector System and Methods of Operation”, which claims priority to U.S.Provisional Patent Application No. 61/228,294, filed Jul. 24, 2009,entitled “Multi-Fluid Medical Injector System and Methods of Operation,”and all of which are hereby incorporated into this application byreference as if fully set forth herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention described herein relates to medical fluid deliveryapplications and, particularly, the automated delivery of one or moremedical fluids to a patient undergoing a medical diagnostic ortherapeutic procedure.

2. Description of Related Art

In many medical diagnostic and therapeutic procedures, a medicalpractitioner such as a physician injects a patient with a fluid. Inrecent years, a number of injector-actuated syringes and poweredinjectors for pressurized injection of fluids, such as contrast media(often referred to simply as “contrast”), have been developed for use inprocedures such as angiography, computed tomography (CT), ultrasound,and NMR/MRI. In general, these powered injectors are designed to delivera preset amount of contrast at a preset flow rate.

Angiography is used in the detection and treatment of abnormalities orrestrictions in blood vessels. In an angiographic procedure, aradiographic image of a vascular structure is obtained through the useof a radiographic contrast which is injected through a catheter. Thevascular structures in fluid connection with the vein or artery in whichthe contrast is injected are filled with contrast. X-rays passingthrough the region of interest are absorbed by the contrast, causing aradiographic outline or image of blood vessels containing the contrast.The resulting images can be displayed on, for example, a video monitorand recorded.

In a typical angiographic procedure, the medical practitioner places acardiac catheter into a vein or artery. The catheter is connected toeither a manual or to an automatic contrast injection mechanism. Atypical manual contrast injection mechanism includes a syringe in fluidconnection with a catheter connection. The fluid path also includes, forexample, a source of contrast, a source of flushing fluid, typicallysaline, and a pressure transducer to measure patient blood pressure. Ina typical system, the source of contrast is connected to the fluid pathvia a valve, for example, a three-way stopcock. The source of saline andthe pressure transducer may also be connected to the fluid path viaadditional valves, again such as stopcocks. The operator of the manualcontrast injection mechanism controls the syringe and each of the valvesto draw saline or contrast into the syringe and to inject the contrastor saline into the patient through the catheter connection. The operatorof the syringe may adjust the flow rate and volume of injection byaltering the force applied to the plunger of the syringe. Thus, manualsources of fluid pressure and flow used in medical applications, such assyringes and manifolds, typically require operator effort that providesfeedback of the fluid pressure/flow generated to the operator. Thefeedback is desirable, but the operator effort often leads to fatigue.Thus, fluid pressure and flow may vary depending on the operator'sstrength and technique.

Automatic contrast injection mechanisms typically include a syringeconnected to a powered injector having, for example, a powered linearactuator. Typically, an operator enters settings into an electroniccontrol system of the powered injector for a fixed volume of contrastand a fixed rate of injection. In many systems, there is no interactivecontrol between the operator and the powered injector, except to startor stop the injection. A change in flow rate in such systems occurs bystopping the machine and resetting the injection parameters.Nonetheless, automatic contrast injection mechanisms provide improvedcontrol over manual apparatus where successful use of such manualdevices is dependent on the skill of the medical practitioner operatingthe device.

While manual and automated injectors are known in the medical field,improved fluid delivery systems adapted for use in medical diagnosticand therapeutic procedures where one or more fluids are supplied to apatient during the procedure continue to be in demand in the medicalfield. Additionally, improved fluid transfer sets and flow controllingand regulating devices associated therewith that may be used with fluiddelivery systems for conducting and regulating fluids flows are alsodesired in the medical field. Moreover, the medical field continues todemand improved medical devices and systems used to supply fluids topatients during medical procedures such as angiography, computedtomography, ultrasound, and NMR/MRI.

SUMMARY OF THE INVENTION

While various embodiments of a fluid injector system, desirably amulti-fluid injector system and methods of operation thereof aredescribed in detail herein, one embodiment of such a fluid injectorsystem comprises a powered injector, a pressure jacket support, asyringe pressure jacket, and a syringe. The pressure jacket supportcomprises a front plate and a rear plate. The rear plate is connected tothe injector and the front plate is spaced from the rear plate anddefines a slot. The syringe pressure jacket has a proximal end pivotallyconnected to the rear plate so that a distal end of the pressure jacketpivots relative to the front plate. The syringe comprises a syringe bodywith a distally extending discharge conduit. With the syringe disposedin a barrel of the pressure jacket, pivotal movement of the pressurejacket distal end toward the front plate places the discharge conduitwithin the slot in the front plate.

In one variation, the discharge conduit may be offset from a centrallongitudinal axis of the syringe body. Additionally, the syringe bodymay comprise a conical distal end and the front plate may define amating recess for the conical distal end such that the conical distalend engages the mating recess as the discharge conduit is received inthe slot in the front plate. The mating recess may be offset from theslot. Alternatively, the slot in the front plate may generally bisectthe mating recess. The front plate and the rear plate may be connectedby a center beam. The syringe body may comprise a conical distal end andthe front plate defines a mating recess for the conical distal end suchthat the conical distal end engages the mating recess and an apex of theconical distal end is received in an apex curve formed in the matingrecess as the discharge conduit is received in the slot in the frontplate.

The syringe body may comprise at least one key element and the pressurejacket may define at least one internal slot or keyway for receiving theat least one key element to orient the syringe body in the pressurejacket.

A fluid control valve may be connected to the discharge conduitextending from the syringe body, and the fluid control valve maycomprise one of a stopcock, a piston valve, and a dual check valve.

In another embodiment, the fluid injector system comprises a poweredinjector, a pressure jacket support, a syringe pressure jacket, asyringe, and a fluid control module. The pressure jacket supportcomprises a front plate and a rear plate. The rear plate is connected tothe injector and the front plate is spaced from the rear plate anddefines a slot. The syringe pressure jacket has a proximal end pivotallyconnected to the rear plate so that a distal end of the pressure jacketpivots relative to the front plate. The syringe comprises a syringe bodywith a distally extending discharge conduit. The fluid control module isconnected to the front plate. With the syringe disposed in a barrel ofthe pressure jacket, pivotal movement of the pressure jacket distal endtoward the front plate places the discharge conduit within the slot inthe front plate.

In one variation, the discharge conduit may be offset from a centrallongitudinal axis of the syringe body. Additionally, the syringe bodymay comprise a conical distal end and the front plate may define amating recess for the conical distal end such that the conical distalend engages the mating recess as the discharge conduit is received inthe slot in the front plate. The mating recess may be offset from theslot. Alternatively, the slot in the front plate may bisect the matingrecess. The front plate and the rear plate may be connected by a centerbeam. The syringe body may comprise a conical distal end and the frontplate defines a mating recess for the conical distal end such that theconical distal end engages the mating recess and an apex of the conicaldistal end is received in an apex curve formed in the mating recess asthe discharge conduit is received in the slot in the front plate.

The syringe body may comprise at least one key element and the pressurejacket may define at least one internal slot or keyway for receiving theat least one key element to orient the syringe body in the pressurejacket.

A fluid control valve may be connected to the discharge conduitextending from the syringe body, and the fluid control valve maycomprise one of a stopcock, a piston valve, and dual check valve. Thepivotal movement of the pressure jacket distal end toward the frontplate may operatively interface the fluid control valve with the fluidcontrol module. The fluid control module may comprise a control valveactuator that operates the fluid control valve.

Various methods of operating the embodiments of the fluid injectorsystem are described in detail in this disclosure. In one embodiment,the method comprises providing a powered injector. The powered injectorcomprises a pressure jacket support and a syringe pressure jacket. Thepressure jacket support comprises a front plate and a rear plate, withthe rear plate connected to the injector. The front plate is spaced fromthe rear plate and defines a slot. The syringe pressure jacket has aproximal end pivotally connected to the rear plate so that a distal endof the pressure jacket pivots relative to the front plate. In themethod, the syringe is loaded into a barrel of the pressure jacket, andthe syringe comprises a syringe body with a distally extending dischargeconduit. The pressure jacket is then pivoted so that the pressure jacketdistal end pivots toward the front plate to place the discharge conduitwithin the slot in the front plate.

In one variation, the discharge conduit may be offset from a centrallongitudinal axis of the syringe body. Additionally, the syringe bodymay comprise a conical distal end and the front plate may define amating recess for the conical distal end such that the conical distalend engages the mating recess as the discharge conduit is received inthe slot in the front plate. The mating recess may be offset from theslot. Alternatively, the slot in the front plate may bisect the matingrecess.

When utilizing a syringe wherein the discharge conduit is offset from acentral longitudinal axis of the syringe body, the method may furthercomprise pivoting the injector onto one lateral side to orient thedischarge conduit to a top position on the syringe body and a fluidpriming and an air purging procedure may be performed on the syringe.Additionally, the injector may be pivoted onto its opposing lateral sideto orient the discharge conduit to a bottom position on the syringe bodyand a single-use fluid delivery set may be generally associated with thesyringe. The method may further comprise performing a fluid priming andan air purging procedure on the single-use fluid delivery set.

A method of operating the fluid injector system is also detailed hereinwith a focus on fluid priming and air purging of components of thesystem. This method generally comprises providing a powered injectorcomprising a pressure jacket supporting a syringe. The syringe comprisesa syringe body with a distally extending discharge conduit and thedischarge conduit is offset from a central longitudinal axis of thesyringe body. The injector is pivoted onto one lateral side to orientthe discharge conduit to a top position on the syringe body and a fluidpriming and an air purging procedure is performed on the syringe.Additionally, the injector may be pivoted onto its opposing lateral sideto orient the discharge conduit to a bottom position on the syringe bodyfor use in an injection procedure on a patient. Additionally, asingle-use fluid delivery set may be placed in association with thesyringe so as to be in fluid communication with the syringe body, afluid priming and an air purging procedure may be performed on thesingle-use fluid delivery set.

Further details and advantages of the various embodiments detailedherein will become clear upon reviewing the following detaileddescription of the various embodiments in conjunction with theaccompanying drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a fluid injector system according to oneembodiment.

FIG. 2 is a front perspective view of a forward portion of the fluidinjector system of FIG. 1.

FIG. 3 is a top perspective view of the forward portion of the fluidinjector system of FIG. 1.

FIG. 4 is a perspective view of a syringe adapted for use in the fluidinjector system of FIG. 1.

FIG. 5 is a longitudinal cross-sectional view of the syringe of FIG. 4taken along Line 5-5 in FIG. 4.

FIG. 6 is a detail view of Detail 6 in FIG. 5.

FIG. 7 is a perspective view showing the syringe of FIG. 4 loaded into apressure jacket of the fluid injector system of FIG. 1.

FIG. 8 is a front view of the view shown in FIG. 7.

FIG. 9 is a cross-sectional view of a front portion of the pressurejacket and loaded syringe in the view of FIG. 7, as taken along Line 9-9in FIG. 8.

FIG. 10 is a detail view of Detail 10 in FIG. 8.

FIGS. 11A-11E illustrate a loading sequence for loading the syringe intothe pressure jacket.

FIG. 12 is a cross-sectional view of the fluid injector system of FIG. 1showing the syringe loaded into the pressure jacket.

FIG. 13 is a top perspective view of the fluid injector system of FIG. 1showing a pair of syringes interfaced with a front plate of a pressurejacket support in the fluid injector system of FIG. 1.

FIG. 14 is a close-up perspective of the view shown in FIG. 13.

FIG. 15 is a top perspective view of the fluid injector system of FIG. 1showing a fluid control module of the system and a first embodiment of afluid control valve interfaced with the fluid control module.

FIG. 16 is a longitudinal cross-sectional view of the fluid injectorsystem shown in FIG. 1 and showing the fluid control module with theassociated fluid control valve as shown in FIG. 15.

FIG. 17 is an isolation perspective view of the fluid control module ofthe fluid injector system of FIG. 1.

FIG. 18 is a front view of the fluid control module shown in FIG. 17.

FIG. 19 is a cross-sectional view taken along Line 19-19 in FIG. 18.

FIG. 20 is an exploded perspective view of the fluid control moduleshown in FIG. 17.

FIG. 21 is a top perspective view of a forward portion of the fluidinjector system of FIG. 1 showing the fluid control module of the systemand a second embodiment of a fluid control valve interfaced with thefluid control module.

FIG. 22 is a longitudinal cross-sectional view of the fluid injectorsystem shown in FIG. 1 and showing the fluid control module with theassociated fluid control valve as shown in FIG. 21.

FIG. 23 is a top perspective view of a forward portion of the fluidinjector system of FIG. 1 showing the fluid control module of the systemand a third embodiment of a fluid control valve interfaced with thefluid control module.

FIG. 24A is a longitudinal cross-sectional view of the fluid injectorsystem shown in FIG. 1 and showing the fluid control module with theassociated fluid control valve as shown in FIG. 23.

FIG. 24B is a detail view of Detail 24B in FIG. 24A.

FIG. 25 is a perspective view of another embodiment of the fluidinjector system of FIG. 1.

FIG. 26 is a perspective view of a forward portion of the fluid injectorsystem of FIG. 25.

FIG. 27 is a perspective view of a fluid connector used to make fluidconnections in the fluid injector system of FIG. 25.

FIG. 28 is an exploded perspective view of the fluid connector shown inFIG. 27.

FIG. 29 is a cross-sectional view of the fluid connector shown in FIG.27.

FIG. 30 is a perspective view of a secondary air detector module adaptedfor use with the various embodiments of the fluid injector system.

FIG. 31 is a cross-sectional view taken along Line 31-31 in FIG. 30.

FIG. 32 is a cross-sectional view taken along Line 32-32 in FIG. 30.

FIG. 33A is a perspective view showing a fluid priming and air purgingorientation of the fluid injector system of FIG. 1.

FIG. 33B is a detail view of Detail 33B in FIG. 33A.

FIG. 34A is a perspective view showing the fluid injector system of FIG.1 in an intermediate position while transitioning to a generallyhorizontal orientation.

FIG. 34B is a detail view of Detail 34B in FIG. 34A.

FIG. 35A is a perspective view showing the fluid injector system of FIG.1 in a generally horizontal orientation.

FIG. 35B is a detail view of Detail 35B in FIG. 35A.

FIG. 36A is a perspective view showing the fluid injector system of FIG.1 in an intermediate position while transitioning to an injectionorientation.

FIG. 36B is a detail view of Detail 36B in FIG. 36A.

FIG. 37A is a perspective view showing the injection orientation of thefluid injector system of FIG. 1.

FIG. 37B is a detail view of Detail 37B in FIG. 37A.

FIG. 38 is a front view of the fluid injector system of FIG. 1 showing apedestal support for supporting the fluid injector system.

FIG. 39 is a front view of the fluid injector system of FIG. 1 showing avariation of the pedestal support shown in FIG. 38.

FIG. 40 is a perspective view of another embodiment of the fluidinjector system of FIG. 1.

FIG. 41 is a top view of a forward portion of the fluid injector systemshown in FIG. 40 and illustrating a fluid delivery set used in thesystem.

FIG. 42 is a perspective view of a Y-connector conduit used in the fluiddelivery set shown in FIG. 40.

FIG. 43 is a perspective view of additional components of the fluiddelivery set of FIG. 40.

FIGS. 44A-44I are respective cross-sectional views illustrating asequence of interfacing a syringe plunger in the syringe of FIG. 4 witha piston element of a powered injector of the fluid injector system ofFIG. 1 according to a first embodiment.

FIGS. 45A-45H are respective cross-sectional views illustrating asequence of interfacing a syringe plunger in the syringe of FIG. 4 witha piston element of the powered injector of the fluid injector system ofFIG. 1 according to a second embodiment.

FIGS. 46A-46I are respective cross-sectional views illustrating asequence of interfacing a syringe plunger in the syringe of FIG. 4 witha piston element of the powered injector of the fluid injector system ofFIG. 1 according to a third embodiment.

FIGS. 47A-47I are respective cross-sectional views illustrating asequence of interfacing a syringe plunger in the syringe of FIG. 4 witha piston element of the powered injector of the fluid injector system ofFIG. 1 according to a fourth embodiment.

FIGS. 48A-48D are respective cross-sectional views illustrating asequence of interfacing a syringe plunger in the syringe of FIG. 4 witha piston element of a powered injector of the fluid injector system ofFIG. 1 according to a fifth embodiment.

FIG. 49 is a top view of another embodiment of the fluid injector systemof FIG. 1.

FIG. 50 is a cross-sectional view of the fluid injector system of FIG.49 taken along Line 50-50 in FIG. 49.

FIG. 51 is a detail cross-sectional view of Detail 51 in FIG. 50.

FIG. 52 is an exploded perspective view of a syringe and fluid controlvalve adapted for use in the fluid injector system of FIG. 49.

FIG. 53 is a cross-sectional view of the syringe shown in FIG. 52 takenalong Line 53-53 in FIG. 52.

FIG. 54 is a detail cross-sectional view of Detail 54 in FIG. 53.

FIG. 55 is an assembled perspective view of the syringe and fluidcontrol valve shown in FIG. 52.

FIG. 56 is a cross-sectional view of the syringe and fluid control valveshown in FIG. 55 taken along Line 56-56 in FIG. 55.

FIGS. 57A-57C are front views of the fluid injector system of FIG. 49illustrating movement of the fluid injector system from a generallyhorizontal orientation to a generally vertical orientation.

FIGS. 58A-58C are rear views of the fluid injector system of FIG. 49illustrating the same sequence of movement shown in FIGS. 57A-57C butfrom the reverse side of the fluid injector system.

FIGS. 59A-59C are front side views of the fluid injector system of FIG.49 illustrating the sequence of movement shown in FIGS. 57A-57C but fromthe front side of the fluid injector system.

FIG. 60 is a perspective view of another embodiment of the fluidinjector system of FIG. 1.

FIG. 61 is a front perspective view of a forward portion of the fluidinjector system of FIG. 60.

FIG. 62 is a top perspective view of the forward portion of the fluidinjector system of FIG. 60.

FIG. 63 is a perspective view of another embodiment of the fluidinjector system of FIG. 1.

FIG. 64 is a front perspective view of the fluid injector system of FIG.63.

FIG. 65 is a top perspective view of a forward portion of the fluidinjector system of FIG. 62.

FIG. 66 is a schematic view of a blood vessel shown with an indwellingcatheter for illustrating an application use of the various embodimentsof the fluid injector system.

DESCRIPTION OF THE INVENTION

For purposes of the description hereinafter, spatial orientation terms,as used, shall relate to the referenced embodiment as it is oriented inthe accompanying drawing figures or otherwise described in the followingdetailed description. However, it is to be understood that theembodiments described hereinafter may assume many alternative variationsand configurations. It is also to be understood that the specificcomponents, devices, and features illustrated in the accompanyingdrawing figures and described herein are simply exemplary and should notbe considered as limiting.

Referring initially to FIGS. 1-14, an embodiment of a multi-fluidmedical injection/injector system 10 is shown. Multi-fluid medicalinjection/injector system 10 (hereinafter “fluid injector system 10”)comprises multiple components as individually described herein.Generally, fluid injector system 10 comprises a powered injectoradministrator or device 20 and a fluid delivery set 1000 intended to beassociated with the injector 20 to conduct one or more fluids underpressure into a patient intravenously via a patient catheter. Thevarious devices, components, and features of the injector 20 and thefluid delivery set 1000 are likewise described in detail herein. Influid injector system 10, a pressure jacket support assembly or element100 is supported to a distal end of the injector 20, a fluid controlmodule 200 is supported from a distal end of the pressure jacket supportassembly or element 100, and an air detector module 300 is disposeddistally of the fluid control module 200 and supported thereto. Thefluid delivery set 1000 is intended to be associated with the injector20 so as to physically interface therewith and, further, physicallyinterface with the pressure jacket support assembly or element 100,fluid control module 200, and air detector module 300. While details offluid delivery set 1000 are provided herein, the fluid delivery set 1000generally comprises a multi-use fluid delivery set 1100 and a single-usefluid delivery set 1500.

Injector 20 is desirably at least a dual-syringe injector, wherein twofluid delivery syringes are oriented in a side-by-side relationship andwhich are separately actuated by respective piston elements associatedwith the injector 20. A suitable injector for this purpose is aStellant™ injector manufactured by Medrad, Inc. of Pittsburgh, Pa.Details of the Stellant™ injector may be found in U.S. Pat. No.7,018,363 (Cowan, et al.) and in United States Patent ApplicationPublication Nos. 2004/0064041 (Lazzaro et al.) and 2005/0113754 (Cowan),each of which is incorporated herein by reference.

Generally, injector 20 comprises an injector housing 22 comprisingopposed lateral sides 24, a distal end 26, and a proximal end 28.Injector housing 22 encloses the various mechanical drive components,electrical and power components necessary to drive the mechanical drivecomponents, and control components such as electronic memory andelectronic control devices (hereinafter “electronic control device(s)”)used to discretely control operation of reciprocally movable pistonelements 60 associated with injector 20 which are described later inthis disclosure in connection with FIGS. 44-48. Such piston elements 60may be reciprocally operable via electro-mechanical drive componentssuch as a ball screw shaft driven by a motor, a voice coil actuator, arack-and-pinion gear drive, a linear motor, and the like.

Injector 20 includes one or more display windows 32 desirably in theform of a graphical user interface (GUI) display window as is well-knownin the powered medical injector field. Display window(s) 32, as is knownin the powered medical injector field, may display information pertinentto a fluid injection procedure involving fluid injector system 10, suchas current flow rate, fluid pressure, and volume remaining in fluidsources connected to fluid delivery set 1000, as non-limiting examples.Moreover, it will be appreciated that while the display windows 32 areshown on the injector housing 22, such display windows 32 may also beremote displays from the injector housing 22 that are wired orwirelessly linked to the injector 20. Additionally, injector 20 maycomprise one or more (e.g., a plurality of) control buttons 34 fortactile operation by an attendant operator of injector 20. These controlbuttons may be hard-wired to the electronic control device(s) associatedwith injector 20 to provide direct input to the electronic controldevice(s). Such control buttons 34 may also be graphically part of thegraphical user interface display window 32 as will be readily clear toone skilled in the powered medical injector field. In eitherarrangement, the control buttons 34 provide certain individual controlfeatures to the attendant operator of injector 20, such as but notlimited to: (1) Acknowledge/Start; (2) Fill/Purge; (3) Forward; (4)Unload; and (5) Stop. Injector 20 also includes a pedestal support 90comprising a support column 92 (see FIGS. 38-39 discussed herein) usedto support the injector 20 and the fluid injector system 10 generally.

The distal end 26 of injector housing 22 defines an open distal end ofthe injector housing 22 for interfacing with pressure jacket supportassembly/element 100, (hereinafter “pressure jacket support 100”).Pressure jacket support 100 may be a multi-component support structurefor supporting a syringe pressure jacket 136 used to limit radialexpansion of a syringe 1120 associated with multi-use fluid delivery set1100 of fluid delivery set 1000 as described herein. As will be apparentfrom FIG. 1, pressure jacket support 100 is configured to support a pairof syringe pressure jackets 136 in side-by-side relationship whichsupport respective syringes 1120 associated with multi-use fluiddelivery set 1100. As is well-known in the powered medical injectorfield, the use of a syringe pressure jacket limits radial expansion of asyringe when under pressure which may lead to bursting or to leaks ofthe pressurized fluid around the seal(s) of the syringe plunger. Anotherfunction of pressure jacket support 100 is to limit and substantiallyprevent forward motion of syringes 1120 relative to injector 20 as thepiston elements 60 associated with injector 20 move syringe plungers inthe respective syringes 1120; the details of the syringes 1120 used withthe injector 20 and the interfacing of piston elements 60 with thesyringe plungers in the syringes 1120 is described in detail herein.

Pressure jacket support 100 generally comprises two opposed supportplates 102, 112 joined by a center beam 124. The connection betweensupport plates 102, 112 via center beam 124 provides an overall I-beamconstruction or shape for pressure jacket support 100 with the centerbeam 124 generally forming the web portion of the I-beam. With thisconstruction, respective adjacent spaces 104 are defined on opposingsides of center beam 124 wherein the respective pressure jackets 136 aredisposed and operable. Rear or proximal plate 102 may have a profiledshape 106 adapted to be inserted into the open distal end 26 of theinjector housing 22. Such a profiled shape 106 may include terracedledges 108 for interfacing with the open distal end 26 of injector 20.Additionally, respective front openings 110 are defined in rear plate102 to allow passage of the piston elements 60 associated with theinjector 20 so that the piston elements 60 may interface with syringeplungers in syringes 1120 that are loaded into the respective pressurejackets 136.

Front or distal plate 112 comprises a front or distal side 114 and arear or proximal side 116. Respective recesses 118 are defined in rearside 116 to face pressure jackets 136 and the syringes 1120 are loadedtherein as described herein. Recesses 118 comprise a central apex curveor area 120 to accommodate a distal tip of the respective syringes 1120and lateral mating contact surfaces 121 are present on either side ofcentral apex curve 120 to contact and interface with the distal end ofeach of the syringes 1120. Slots 122 are defined vertically in frontplate 112 and are offset laterally from the respective recesses 118 toaccommodate a discharge outlet extending from syringes 1120; specificfeatures of the syringes 1120 adapted for use with pressure jackets 136in pressure jacket support 100 are described herein. The front side 114of front plate 112 provides a support/mounting location for the fluidcontrol module 200 as described herein.

Center beam 124 generally defines an inverted T-shape in transversecross-section which defines the respective pressure jacket operatingspaces 104. While the rear plate 102, front plate 112, and center beam124 are illustrated in the accompanying drawing figures and described inthe foregoing as distinct elements, these individual components orelements may be formed as an integral, unitary component. However, therear plate 102, front plate 112, and center beam 124 are typicallymechanically connected together through use of conventional mechanicalfasteners or joined via permanent joining methods such as by welding. Itis desirable to form the rear plate 102, front plate 112, and centerbeam 124 from metal such as stainless steel of a grade suitable for usein medical environments but these components may alternatively be madeof any material(s) that provides sufficient structural strength towithstand the operational pressures associated with operation ofsyringes 1120 in pressure jackets 136. As an example, a force of 2,400pounds is typically required to restrain the forward motion of a 150 mlsyringe with a cross-section of 2.0 in.sup.2 at 1,200 p.s.i. Mountingflanges 134 are provided on the front side of the rear plate 102 formounting the respective pressure jackets 136 to the rear plate 102.

In the present embodiment, dual pressure jackets 136 are provided forthe dual-syringe injector 20. Each pressure jacket 136 operates in apressure jacket operating space 104 defined by the pressure jacketsupport 100. Each pressure jacket 136 generally has a proximal end 138and a distal end 140. In the illustrated embodiment, each pressurejacket 136 is a composite two-piece structure comprised of a proximalcylindrical flange portion 142 and a distal cylindrical body portion152. While the flange portion 142 and body portion 152 are illustratedas separate components, these components may alternatively be integrallyformed as a unitary component. In the illustrated embodiment, flangeportion 142 is desirably formed of metal such as aluminum or stainlesssteel selected from a grade suitable for medical environments and bodyportion 152 is desirably formed of a transparent plastic material suchas polycarbonate and like relatively rigid plastic materials that aresuited to restraining radial expansion of syringes 1120 loaded intopressure jackets 136. Flange portion 142 has a distal rim or end 144 anda proximal rim or end 146. Likewise, body portion 152 has a distal rimor end 154 and a proximal rim or end 156. An overlapping joint 170 isformed at the joining location of the flange portion 142 and the bodyportion 152 and the overlapped joint 170 may be secured by joiningmethods customary in the medical field such as by a suitable medicalgrade adhesive, solvent bonding, ultrasonic welding friction fitengagement, threaded engagement, etc. In particular, the overlappedjoint 170 is formed between overlapping areas on the distal rim 144 ofthe flange portion 142 and the proximal rim 156 of the body portion 152.The flange portion 142 of each pressure jacket 136 further comprises twoexternal and outward extending mounting hubs 148 for forming a pivotalconnection with a corresponding mounting flange 134 on the front side ofthe rear plate 102 and with a pivot location on the center beam 124. Asillustrated, each pressure jacket 136 is pivotally supported by mountinghubs 148 to one of the mounting flanges 134 on the rear plate 102 and apivot location on the center beam 124 of pressure jacket support 100.Such pivotal connections may be made through the use of suitablemechanical fasteners. It is noted that the mounting hubs 148 on theflange portion 142 of each pressure jacket 136 are offset above a planeB which bisects the pressure jacket 136 longitudinally and, thus, apivot axis P of each pressure jacket 136 is located above the bisectingplane B shown in FIG. 8. Mounting flanges 134 are similarly offset abovesuch a bisecting horizontal plane B. As shown in the view of FIG. 11,when the respective pressure jackets 136 are disposed in a generallyhorizontal orientation within the respective pressure jacket operatingspaces 104 and a horizontal plane H shown in these figures iscoextensive with the longitudinal bisecting plane B passing through thepressure jacket 136. The purpose and function of the foregoing offsetarrangements are described herein. Briefly, however, each pressurejacket 136 is adapted to pivot upward in its operating space 104 toallow loading of syringes 1120 therein. In order to permit this upwardpivoting movement of the pressure jackets 136, the respective frontopenings 110 in rear plate 102 are positioned and sized to allow theproximal or rear rim 146 on the flange portion 142 of each pressurejacket 136 to pivot at least partially into the respective frontopenings 110. More particularly, front openings 110 are of sufficientsize to allow clearance for the proximal or rear rim 146 on the flangeportion 142 of each pressure jacket 136 as the pressure jackets 136 arepivoted upward to allow loading of syringes 1120 therein.

A further feature of each pressure jacket 136 comprises the provision ofa keyway 158 defined in the distal rim 154 of the body portion 152 ofeach pressure jacket 136. The keyway 158 is defined in an interiorsurface 160 of the body portion 152 at the distal rim 154. Two slots orkeyways 158 may be defined in the interior surface 160 of the bodyportion 152 of each pressure jacket 136 and extend substantially orgenerally parallel to one another. However, the accompanying figuresillustrate only one keyway 158. As will be understood from theforegoing, the flange portion 142 and the body portion 152 of eachpressure jacket 136 together generally define a receiving bore or barrel162 of the pressure jacket 136 for receiving a syringe 1120 associatedwith multi-use fluid delivery set 1100 of fluid delivery set 1000.

As noted in the foregoing, fluid delivery set 1000 generally comprises amulti-use fluid delivery set 1100 and a single-use fluid delivery set1500. While both the multi-use fluid delivery set 1100 and thesingle-use fluid delivery set 1500 are intended to be disposable items,it is envisioned that the multi-use fluid delivery set 1100 (hereinafter“multi-use set 1100”) may be reused a set number of times and/or for aset number of patients whereas single-use fluid delivery set 1500(hereinafter “single-use set 1500”) is intended to be a single-use orper-patient use set pursuant to the concepts outlined in U.S. Pat. No.5,840,026 (Uber, III); U.S. Pat. No. 5,843,037 (Uber, III); and U.S.Pat. No. 5,806,519 (Evans, III, et al.), all incorporated herein byreference in their entirety. As further noted in the foregoing, syringe1120 is one component or part of multi-use set 1100, with additionalcomponents or parts thereof described herein. In the set-up orready-for-use state of fluid injector system 10, two multi-use sets 1100and one single-use set 1500 are typically installed, with each multi-useset 1100 comprising a syringe 1120 loaded into the receiving bore orbarrel 162 of a corresponding pressure jacket 136. The followingdiscussion describes one of the multi-use sets 1100 adapted for use withfluid injector system 10.

The syringe 1120 in each multi-use set 1100 comprises an elongated,cylindrical syringe body 1122 having a front or distal end 1124 and arear or proximal end 1126. A syringe plunger 1300 is disposed within thesyringe body 1122 and various embodiments of the syringe plunger 1300are described herein in this disclosure for interfacing with thereciprocally operable piston elements 60 associated with injector 20.The distal end 1124 of the syringe body 1122 is generally conical-shapedand tapers to an apex or cone point 1128 which is adapted to interfacewith the central apex curve 120 formed in the recess(es) 118 defined inthe rear or proximal side 116 of the front plate 112 as describedfurther herein. Syringe apex or cone point 1128 is located along acentral longitudinal axis L of the syringe body 1122. In onenon-limiting embodiment, the tapered distal end 1124 of syringe body1122 tapers at an angle of about 22.degree. In addition, the syringebody 1122 comprises a discharge outlet or conduit 1130 that is offsetfrom the central longitudinal axis L of the syringe body. Dischargeoutlet or conduit 1130 is formed to extend distally from a sidewall 1132of the syringe body 1122 so that a discharge port 1134 defined by thedischarge outlet 1130 is situated immediately adjacent the sidewall 1132of the syringe body 1122 and at the base of the cone defined by theconical-shaped distal end 1124 of the syringe body 1122. Dischargeoutlet 1130 may be formed with a conventional luer fitting-typeconnection to mate with additional downstream components of themulti-use set 1100 as described herein.

The proximal end 1126 of syringe body 1122 is desirably formed with anexpansion section 1138. A generally cylindrical “working” section 1140of syringe body 1122 connects the distal and proximal ends 1124, 1126 ofthe syringe body 1122 and is defined essentially forward or distal ofthe expansion or storage section 1138 of syringe body 1122. Thecylindrical section 1140 of the syringe body 1122 has a relativelyuniform outer diameter. The expansion section 1138 is provided generallyas a storage section or area for the syringe plunger 1300. The expansionsection 1138 is preferably formed at the proximal end 1126 of syringebody 1122 but may optionally be formed at a different location along thesyringe body 1122. Generally, the expansion section 1138 is formed bythe sidewall 1132 of syringe body 1122 narrowing to a reduced wallthickness t.sub.r from a thickness t of the sidewall 1132 in the mainbody cylindrical section 1140 of the syringe body 1122. Thus, an innerdiameter of the expansion section 1138 is larger than an inner diameterof the main body cylindrical section 1140 of the syringe body 1122 andthe resulting reduced wall thickness t.sub.r at the expansion section1138 allows the expansion section 1138 to expand outward under radialforce exerted by the syringe plunger 1300 during storage periods. Theexpansion section 1138 thereby accommodates plastic creep of the syringebody 1122 even after long periods of storage. Even after long storageperiods, the syringe 1120 with a pre-positioned syringe plunger 1300 maybe quickly and easily actuated to move from the storage/expansionsection 1138 into the cylindrical section 1140 of the syringe body 1122.Typically, once the syringe 1120 is inserted into its receiving pressurejacket 136 in the manner to be described herein, the injector 20 isactuated to move the corresponding piston element 60 forward or distallyto engage the syringe plunger 1300 stored within the storage/expansionsection 1138 of the syringe body 1122 of the syringe 1120. Thereafter,the piston element 60 may move the engaged syringe plunger 1300 into themain body cylindrical section 1140 of the syringe body 1122 of thesyringe 1120.

The proximal end 1126 of the syringe body 1122 is formed with an outwardextending lip 1142 to provide strength and rigidity to thestorage/expansion section 1138 of the syringe body 1122. The proximal orrear lip 1142 may perform other functions such as engaging contactsensor(s) and like components or devices associated with the injector 20which may be used, for example, to determine if a syringe 1120 ispresent within the corresponding pressure jacket 136. However, it ispreferred that the proximal or rear lip 1142 have an outer diameterapproximately the same as the outer diameter of the main bodycylindrical section 1140 of the syringe body 1122 so that the syringe1120 may be smoothly accepted into the receiving barrel or bore 162 ofthe pressure jacket 136.

Additionally, the syringe body 1122 further comprises one or more key ortab elements 1144 formed on the main body or working section 1140 of thesyringe body 1122 and immediately adjacent the conical distal end 1124of the syringe body 1122. Key or tab elements 1144 are adapted tointerface with the keyway 158 defined in the inner surface 160 of thebody portion 152 of each pressure jacket 136 when the syringe 1120 isinserted into its receiving pressure jacket 136. Generally, as shown inseveral views of FIGS. 4-9, parallel key or tab elements 1144 areoriented approximately opposite (180.degree.) from the discharge outletor conduit 1130. The syringe body 1122 may be formed of conventionalmaterials used in the medical field to form syringe barrels such aspolycarbonate, polypropylene, etc.

With the foregoing description of the pressure jacket support 100 andthe syringe 1120 in mind, exemplary loading and unloading of a syringe1120 into a receiving pressure jacket 136 will now be described, withspecific reference to FIGS. 11-14. Initially, the receiving pressurejacket 136 is pivoted upward in its pressure jacket operating space 104about the pivotal connection associated with the mounting hubs 148.Pivotal movement is continued until the distal rim or end 154 of thebody portion 152 of the pressure jacket 136 is pivoted above the top offront plate 112 to provide clear access to the barrel or bore 162 of thepressure jacket 136. In this position, a central longitudinal axis ofthe pressure jacket 136 which is coaxial with the central longitudinalaxis L of the syringe body 1122 defines an acute angle with thehorizontal plane H which generally bisects the injector housing 22 asshown in FIGS. 11A-11E. With the barrel 162 of the receiving pressurejacket 136 now accessible, an attendant operator generally orientssyringe body 1122 of syringe 1120 so that key or tab elements 1144 onthe syringe body 1122 are aligned with the keyway 158 defined in theinner surface 160 of the body portion 152 of the receiving pressurejacket 136. Orienting the syringe body 1122 in this manner automaticallyorients discharge outlet 1130 extending distally from the syringe body1122 vertically with the corresponding offset slot 122 defined in thefront plate 112 of the pressure jacket support 100. The syringe 1120 maythen be inserted into the barrel 162 of the pressure jacket 136 andengagement of the key elements 1144 in the keyway 158 defined in theinner surface 160 of the body portion 152 of the pressure jacket 136limits insertion of the syringe body 1122 into the pressure jacket 136.The pressure jacket 136 is then pivoted downward in its pressure jacketoperating space 104 about the pivotal connection associated with themounting hubs 148, thereby decreasing the acute angle as shown in FIGS.11A-11E. Pivotal movement is continued until the discharge outlet 1130extending distally from the syringe body 1122 seats into thecorresponding offset slot 122 defined in the front plate 112 of thepressure jacket support 100. In this position, the pressure jacket 136,now supporting the syringe 1120, is generally horizontal and places thesyringe 1120 in a loaded position ready for use. The centrallongitudinal axis L of the pressure jacket 136 and syringe body 1122 nowaligns with the horizontal plane H.

As will be understood from FIG. 12 in particular, the apex or cone point1128 at the distal end 1124 of syringe body 1122 defines an arcuate orarc-type movement as illustrated by arc path line A as the pressurejacket 136 is pivoted upward/downward from/into pressure jacketoperating space 104 as described in the foregoing. As noted previously,the apex or cone point 1128 at the distal end 1124 of syringe body 1122is adapted to interface with the central apex curve 120 formed in thecorresponding receiving recess 118 defined in the rear or proximal side116 of the front plate 112. This engagement and the mating engagementbetween the conical distal end 1124 of syringe body 1122 and the lateralmating surfaces 121 defined by the receiving recess 118 axiallyrestrains the syringe body 1122 when under pressure. In particular, thecentral apex point 1128 at the distal end 1124 of the syringe body 1122is seated within the central apex curve 120 approximately at a midpointM of the curvature of this curve while the lateral mating surfaces 121contact and support the conical distal end 1124 of the syringe body1122. The foregoing mating features between the central apex point 1128and the receiving central apex curve 120 and between the conical distalend 1124 and the lateral mating surfaces 121 ensures that when thesyringe body 1122 is under pressure by action of the syringe plunger1300, the syringe body 1122 remains centered against the front plate112. The foregoing mating features provide a self-centering action forthe syringe 1120 when loaded in the pressure jacket 136 in aready-for-use state or condition. Without this self-centering action, ifthe syringe body 1122 were pressurized resulting in an upward directedforce applied to the syringe body 1122, a potential exists for acorresponding torque force to be applied to the pressure jacket 136which could cause the pressure jacket 136 to pivot upward about mountinghubs 148 and cause the potential dislodgment of the syringe 1120 fromthe pressure jacket 136.

As noted in the foregoing, each multi-use set 1100 includes, as onecomponent, the syringe 1120 as described previously. The multi-use set1100 further comprises a fluid flow control device, namely, a fluidcontrol valve 1150 which is adapted to interface with the fluid controlmodule 200 as described further herein. Referring further to FIGS.15-16, one embodiment of the fluid control valve 1150 is a three-waystopcock valve 1160. Stopcock valve 1160 comprises a valve body 1161defining three ports, 1162, 1164, and 1166 and a plug 1168 actuated byan actuation handle 1170. First port 1162 is fluidly coupled to thedischarge conduit 1130 on the syringe body 1122 of the syringe 1120 andthis fluid coupling may be a permanent connection provided by anintermediate conduit element 1172 that is bonded to the first port 1162and to the discharge conduit 1130 on the syringe body 1122, for example,by a medical grade adhesive, solvent bonding, ultrasonic welding, andlike joining methods known in the medical field. Alternatively, adisconnecting connection may be provided between the first port 1162 andthe discharge conduit 1130 on the syringe body 1122, for example, by adirect connection between the first port 1162 and the discharge conduit1130 or via an intermediate conduit element similar to the illustratedintermediate conduit element 1172 but having suitable connector ports.Second port 1164 is fluidly coupled to a connecting tubing line 1174having a conventional end connector spike 1175 via connecting tubing1174 which is permanently joined to the second port 1164 via any of thejoining methods set forth in the foregoing. Alternatively, adisconnecting arrangement may be made between the connecting tubing 1174and the second port 1164 if desired. Third port 1166 is provided with afluid connector 1176 which again is desirably permanently affixed to thethird port 1166 via any of the conventional joining methods described inthe foregoing or a disconnecting arrangement may be provided if desired.Due to the pressures generated during operation of the syringe 1120, apermanent and robust fluid connection between the third port 1166 andthe fluid connector 1176 and between the first port 1162 and thedischarge conduit 1130 on the syringe body 1122 of the syringe 1120 isgenerally preferred in accordance with this disclosure. Various suitablemedical connectors for the fluid connector 1176 and details thereof maybe found in United States Patent Application Publication No.2008/0086087 (Spohn et al.) and/or in United States Patent ApplicationPublication No. 2005/0234428 (Spohn et al.), both of which areincorporated herein by reference.

As described previously, two multi-use sets 1100 are provided tointerface, respectively, with the two pressure jackets 136 supported tothe injector 20 via the pressure jacket support 100. As furtherdiscussed in the foregoing, the fluid delivery set 1000 comprises asingle-use set 1500 that interfaces and fluidly couples to therespective multi-use sets 1100 and provides a flow path from themulti-use sets 1100 to a patient. Single-use set 1500 comprises severalcomponents and, generally, a first input line 1502 and a second inputline 1504 each terminating in a fluid connector 1506, a downstreamY-connector 1508, a gravity flow prevention diaphragm valve 1509, apressure isolation valve 1510, a stopcock valve 1512 having an actuationhandle 1513, and a catheter connector conduit 1514. Suitable medicalconnectors for fluid connectors 1506 that have mating features forinterfacing with fluid connectors 1176 provided for the multi-use sets1100 are also described in United States Patent Application PublicationNos. 2008/0086087 and 2005/0234428 (both to Spohn et al.). Details andoperation of the pressure isolation valve 1510 may be found in UnitedStates Patent Application Publication Nos. 2008/0058720 and 2008/0154214(both to Spohn et al.), each incorporated herein by reference.Additional desirable features for incorporation into single-use set 1500for preventing gravity-flow situations may be found in InternationalApplication No. PCT/US2008/076378 (WO/2009/036413), incorporated hereinby reference for this purpose. Moreover, additional aspects ofsingle-use set 1500 may be found in United States Patent ApplicationPublication Nos. 2007/0161970 and 2005/0234407 (both to Spohn et al.),each incorporated herein by reference. Downstream stopcock 1512 may havea number of functions including patient-isolation, waste-dumping, airaspiration, or, possibly, drug injection functions.

Referring further to FIGS. 17-20, fluid control module 200 generallycomprises a housing 202 enclosing a pair of control valve actuators 220.A securing section or area is associated with the fluid control module200 for interfacing with the fluid control valve 1150 provided with eachmulti-use set 1100. Generally, fluid control module housing 202comprises a depending actuator enclosure 204, wherein the respectivecontrol valve actuators 220 are disposed, and a top cover or plate 206for enclosing the actuator enclosure 204. Top cover or plate 206 definestwo separate sets of attachment points or elements 208 arranged in atriad for interfacing with the fluid control valve 1150 provided witheach multi-use set 1100. The attachment points or elements 208 areformed integrally with the cover plate 206 for securing the fluidcontrol valve 1150 provided with each multi-use set 1100 to the fluidcontrol module 200. In one embodiment, the attachment points or elements208 are formed for a snap-fit/friction fit engagement with therespective stopcock valves 1160 and, in particular, via snap-fitengagement with ports 1162, 1164, 1166 on each stopcock valve 1160 as iswell-known in the medical field.

Additionally, the front plate 112 of pressure jacket support 100comprises a distal support flange 210 extending forward from the frontor distal side 114 of the front plate 112 to provide an attachment ormounting location for the actuator enclosure 204 and top cover or plate206. The respective control valve actuators 220 are also mounted to thedistal support flange 210 beneath the distal support flange 210. Asnoted in the foregoing, fluid control module 200 is intended to enclosetwo control valve actuators 220 in actuator enclosure 204 forinterfacing with the respective fluid control valves 1150 associatedwith the two multi-use sets 1100. The syringe 1120 for each suchmulti-use set 1100 interfaces with a pressure jacket 136 supported bypressure jacket support 100 as described in the foregoing. The coverplate 206 defines two top openings or apertures 212 to allow therespective control valve actuators 220 to interface with the respectivefluid control valves 1150 in the multi-use sets 1100. The distal supportflange 210 may be formed integrally with the front plate 112 of pressurejacket support 100 and, therefore, is desirably formed of aluminum orstainless steel of a grade suitable for medical applications as notedpreviously. Actuator enclosure 204 and cover plate 206 may be formed ofa suitable medical grade plastic material and are mounted to the distalsupport flange 210 via mechanical fasteners 214. Each control valveactuator 220 comprises an actuator element 222 disposed in therespective openings 212 in the cover plate 206 enclosing actuatorenclosure 204 for interfacing with the fluid control valve 1150.

As noted previously, orienting the syringe body 1122 in the properconfiguration to align key or tab elements 1144 on the syringe body 1122with the keyway 158 defined in the inner surface 160 of the body portion152 of the pressure jacket 136 automatically orients the dischargeoutlet 1130 extending distally from the syringe body 1122 with thecorresponding offset slot 122 defined in the front plate 112 of thepressure jacket support 100. Once the syringe 1120 is fully insertedinto the barrel 162 of the receiving pressure jacket 136 and engagementof the key elements 1144 in the keyway 158 is complete, the pressurejacket 136 may then pivot downward. Pivotal movement is continued untilthe discharge outlet 1130 extending from the syringe body 1122 seatsinto the corresponding offset slot 122 defined in the front plate 112 ofthe pressure jacket support 100. This pivotal movement alsoautomatically aligns the stopcock valve 1160, in the depictedembodiment, to interface with the corresponding attachment points orelements 208 on the cover plate 206 of the fluid control module housing202. In particular, as the pressure jacket 136 containing a syringe 1120is pivoted downward, ports 1162, 1164, and 1166 are aligned with therespective snap-fit/friction-fit attachment elements 208 on the coverplate 206 and, as the pressure jacket 136 is pivoted to a generallyhorizontal orientation, the respective ports 1162, 1164, and 1166 are ina position for connection to the attachment elements 208. Once theassociated pressure jacket 136 reaches a generally horizontalorientation, the attendant operator may simply press on the valve body1161 of the stopcock valve 1160 so that the respective ports 1162, 1164,and 1166 snap into engagement with the attachment elements 208. Thissnap-fit or frictional-fit connection also locates the actuation handle1170 in a position to mechanically interface with the correspondingactuator element 222 of the control valve actuator 220 disposed withinthe actuator enclosure 204 of the fluid control module 200. As theactuation handle 1170 operates the stopcock plug 1168 of the stopcockvalve 1160, operation of the actuation handle 1170 by the control valveactuator 220 places the stopcock plug 1168 in different operationalstates. As noted previously, the first port 1162 is fluidly coupled tothe discharge conduit 1130 on the syringe body 1122 of the syringe 1120,the second port 1164 is fluidly coupled to a conventional connectorspike 1175 via connecting tubing 1174, and the third port 1166 isprovided with a fluid connector 1176 for interfacing with a mating fluidconnector 1506 on a single-use set 1500. The foregoing loading sequencefor interfacing stopcock valve 1160 with the fluid control module 200 isrepeated for the second multi-use set 1100 to be associated withinjector 20 via pressure jacket 136.

Stopcock valve 1160 is a conventional three-way stopcock whereinstopcock plug 1168 defines a T-shaped intersecting passageway 1178 sothat any two ports 1162, 1164, and 1166 may be connected at any onetime. In the view of FIG. 16, the stopcock valve 1160 associated withthe “lower” or right side syringe 1120 is in a state to permit fluidflow from this syringe 1120 to the third or outlet port 1166, while the“upper” or left side syringe 1120 is in a state to permit fluid flowfrom a source of fluid connected to the connector spike 1175 to thissyringe 1120. A shut-off condition for stopcock valve 1160 may also beprovided by orienting the stopcock plug 1168 in a position wherepassageway 1178 blocks fluid communication between any of ports 1162,1164, 1166. As the view in FIG. 16 further demonstrates, the connectionbetween the respective multi-use sets 1100 and the single-use set 1500is defined substantially at the fluid control module 200 and, moreparticularly, at the third or outlet port 1166 of the stopcock valve1160 via a sterile mating fluid connector arrangement between matingfluid connectors 1176, 1506.

As shown in the exploded view in FIG. 20, the cover plate 206 is formedto seat onto distal support flange 210 extending from front plate 112 ofpressure jacket support 100. The distal support flange 210 definesrespective recesses 224 that correspond to the openings 212 in the coverplate 206 and which rotationally accept the respective actuator elements222. In the illustrated embodiment, the actuator elements 222 comprisesocket elements adapted to receive the stopcock actuation handle 1170 onthe stopcock valves 1160. Additionally, openings 226 are defined inrecesses 224 to allow the respective control valve actuators 220 tomechanically interface with the actuator elements 222. In particular,the control valve actuators 220 each comprise an output shaft 228 thatmechanically interfaces with the respective actuator elements 222 tooperationally control the position of the stopcock actuation handle 1170and, thereby, the operational position of stopcock valve 1160.

Generally, each control valve actuator 220 is adapted to selectivelyposition the stopcock actuation handle 1170 to achieve at least threeset positions of the stopcock valve 1160, namely: (1) an inject or openposition, wherein the first port 1162 is in fluid connection with thethird or outlet port 1166; (2) a fill position, wherein the second port1164 is in fluid connection with the first port 1162 to allow filling ofsyringe 1120 via the connector spike 1175 and connecting tubing 1174associated with a fluid container; and (3) a closed or isolationposition, wherein the first and second ports 1162 and 1164 are isolatedfrom the third or outlet port 1166 and from one another. In an exemplaryembodiment, the control valve actuators 220 may be a DC brush motor or astepper motor secured by mechanical fasteners 230 to an underside of thedistal support flange 210 extending from the front plate 112 of thepressure jacket support 100. In such an embodiment, the output shafts228 from the motors comprising the control valve actuators 220 providethe motive forces for rotational movement of the socket actuatingelements 222 and, thereby, cause operational movement of the stopcockactuation handle 1170.

A further feature of the fluid control module 200 comprises a pair ofsensors 232 adapted to identify when the respective multi-use sets 1100of the overall fluid delivery set 1000 are present in association withthe fluid control module 200. The detector or proximity sensors 232 maybe optical sensors that are seated and secured within a respective pairof annular mounts 234 formed as part of the cover plate 206 whichencloses the actuator enclosure 204. The detector sensors 232 extendthrough a respective pair of receiving openings 236 in the distalsupport flange 210. As will be appreciated by those versed in the fieldof powered medical fluid injectors, detector sensors 232 areelectronically coupled to electronic control device(s) used todiscretely control operation of the reciprocally movable piston elements60 associated with the injector 20 so that operation of the injector 20may be based, at least in part, on inputs from the detector sensors 232.The detector sensor mounts 234 are positioned generally so as to allowthe respective detector sensors 232 to identify when the first port 1162of stopcock valve 1160 is positioned in its receiving attachment pointor element 208 on the cover plate 206 or, desirably, when the connectingelement 1172 between the first port 1162 and the discharge conduit 1130extending from the syringe body 1122 is present near the detector sensor232 which indicates that the discharge conduit 1130 is fully seated inthe receiving slot 122 in the front plate 112 of the pressure jacketsupport 100. Mechanical fasteners 214 may be used to secure the coverplate 206 to the actuator enclosure 204 with the distal support flange210 being sandwiched between these components and likewise held fixed bythe mechanical fasteners. Furthermore, the actuator enclosure 204 maydefine two front recesses 240 to cooperate with support arms used tosupport the air detector module 300 distally outward from the fluidcontrol module 200 as described herein.

The air detector module 300 is generally supported to the fluid controlmodule housing 202 and, in particular, to the cover plate 206 via twodistally extending support arms 302. The support arms 302 support ahousing or body 304 that in turn supports a plurality of air columndetectors 320, (hereinafter “air detectors 320”). In particular, the airdetector module housing 304 is generally a rectangular, box-shapedhousing structure that supports two air detectors 320 located on a topside of cover plate 306 and two air detectors 320 located on a front ordistal side 308. The support arms 302 are joined to a rear or distalside 310 of the housing 304 to support the housing 304 to the fluidcontrol module housing 202. The air detectors 320 may be conventionalultrasonic or optical air detector sensors and each define a detectorrecess 322 for receiving medical tubing associated with the multi-useset 1100 and the single-use set 1500. Each air detector 320 is providedwith a mounting element 324 having a pair of attachment points 326located on either side of the detector recess 322 for receiving andsecuring medical tubing associated with the multi-use set 1100 and thesingle-use set 1500. It is generally desirable for the top-mounted ortop-located air detectors 320 on the air detector module housing 304 tointerface with the input lines 1502, 1504 associated with the single-useset 1500 and for the front-mounted or front-located air detectors 320 onthe air detector module housing 304 to interface with the respectiveconnecting tubing lines 1174 associated with the second port 1164 of therespective stopcock valves 1160 in the multi-use sets 1100. In thismanner, fluid drawn into and dispensed from the syringes 1120 duringtheir operation is subject to air detection when in-coming to thesyringes 1120 and out-going from the syringes 1120. As will beappreciated by those skilled in the powered medical injector field, therespective air detectors 320 are linked to the electronic controldevice(s) associated with the injector 20 which is used to discretelycontrol operation of the reciprocally movable piston elements 60associated with injector 20 for safety and other purposes. A supportbridge 328 may be disposed within the housing 304 to provide asupporting element or base within the housing 304 for attachment of therespective mounting elements 324 supporting the respective air detectors320 as well as an anchoring location for the support arms 302 which, asillustrated, may pass through rear openings in the support bridge 328 tobe affixed to the distal support flange 210 enclosed within the fluidcontrol module housing 202 using conventional mechanical fasteners 330.

Referring next to FIGS. 21-22, another embodiment of the fluid controlvalve 1150 in the form of a piston valve 1180 is illustrated as formingpart of the multi-use set 1100. The piston valve 1180 is anothersuitable embodiment of the fluid control valve 1150 for application influid injector system 10 with appropriate modifications to the fluidcontrol module 200. The piston valve 1180 generally comprises a valvehousing 1181 defining three ports 1182, 1184, and 1186 and a piston1188. The piston 1188 comprises a piston head 1190 and adistally-extending piston stem 1192. The piston stem 1192 defines radialrecesses at spaced apart locations along the piston stem 1192 whereO-rings 1194 and like sealing elements may be seated for forming a fluidtight connection with an internal piston cavity or bore 1200 defined bythe valve housing 1181. Two fluid connecting radial recesses 1196 arealso defined in the piston stem 1192 at spaced apart axial locations toenable operation of the piston valve 1180. The piston head 1190 isformed to be engaged with a modified actuator element 222 of the controlvalve actuator 220 according to a modified embodiment of the controlvalve actuator 220 adapted for interfacing with piston valve 1180, asdescribed herein.

The piston valve 1180 is secured to the cover plate 206 of the fluidcontrol module housing 202 in an analogous manner to the manner in whichthe stopcock valve 1160 is secured to the cover plate 206 but withcertain modifications as now described. In particular, one of theattachment elements 208 on the cover plate 206, in the presentembodiment, is adapted for a snap-fit or friction-fit engagement withthe first port 1182 in an analogous arrangement to thesnap-fit/friction-fit engagement used to secure the first port 1162 ofthe stopcock valve 1160. However, the piston valve housing 1181comprises a radial securing flange 1204 for further securing the pistonvalve housing 1181 to a second, modified attachment element 216 on thecover plate 206 which comprises two opposing walls adapted to receivethe radial securing flange 1204 therebetween. Further, the modifiedactuator element 222 of the control valve actuator 220 may be formed fora snap-fit/friction-fit engagement with the piston head 1190 in asimilar manner to the conventional attachment element 208 or, desirably,the second, modified attachment element 216 on the cover plate 206.

The first port 1182 of the piston valve 1180 is fluidly coupled to thedischarge conduit 1130 on syringe body 1122 of syringe 1120 and thisfluid coupling may be a permanent connection, for example, by a medicalgrade adhesive, solvent bonding, ultrasonic welding, and like joiningmethods known in the medical field. Alternatively, a disconnectingconnection may be provided between the first port 1182 and the dischargeconduit 1130 on the syringe body 1122, for example, by a directconnection between the first port 1182 and the discharge conduit 1130 orvia an intermediate conduit element similar to the intermediate conduitelement 1172 discussed previously in connection with stopcock valve1160. The second port 1184 is fluidly coupled to the conventionalconnector spike 1175 via connecting tubing 1174 in the same mannerdescribed previously in connection with stopcock valve 1160. This fluidconnection may be a permanent connection via any of the methodsdiscussed previously but, alternatively, a disconnecting arrangement maybe made between the connecting tubing 1174 and the second port 1184 ifdesired. The third port 1186 is provided with a fluid connector 1206which again may be permanently affixed to the third port 1186 via any ofthe conventional joining methods described in the foregoing.Nonetheless, a disconnecting arrangement may be employed if desired. Dueto the pressures generated during actuation of the syringe 1120, apermanent and robust fluid connection between the third port 1186 andthe fluid connector 1206 between the first port 1182 and the dischargeconduit 1130 on the syringe body 1122 of the syringe 1120 is generallypreferred in accordance with this disclosure. Fluid connector 1206 issimilar to fluid connector 1176 described previously and is adapted inlike manner to fluid connector 1176 to interface with mating fluidconnector(s) 1506 associated with single-use set 1500; the details forfluid connectors 1176, 1206 and mating fluid connector 1506 may be foundin United States Patent Application Publication No. 2008/0086087 and/orin United States Patent Application Publication No. 2005/0234428, bothof which were incorporated herein previously by reference.

The fluid connecting radial recesses 1196 in piston valve 1180 permitthe first port 1182 to alternately be placed in fluid connection withports 1184, 1186. In the view of FIG. 22, the piston valve 1180associated with the “left” side syringe 1120 is in a state to permitfluid flow from this syringe 1120 to the third or outlet port 1186,while the “right” side syringe 1120 is in a state to permit fluid flowfrom a source of fluid connected to the connector spike 1175 to thissyringe 1120. An intermediate portion 1208 of the piston stem 1192defined between the radial recesses 1196 may be used to block or isolatethe first port 1182 when this intermediate portion 1208 is generallycentered over the first port 1182. In this location, the second andthird ports 1184, 1186 are also isolated from one another. Operation ofthe piston 1188 to move the piston stem 1192 to achieve the variousforegoing fluid connections is effected by engagement of the modifiedactuator element 222 of the control valve actuator 220 with the pistonhead 1190. In the present embodiment, it will be apparent that theassociated control valve actuator 220 useful for operation of the pistonvalve 1180 is desirably a linear actuator capable of imparting linearreciprocal movement to the piston stem 1192 via the piston head 1190.

Referring next to FIGS. 23-24, another embodiment of the fluid controlvalve 1150 is a dual or double check valve 1210. Dual check valve 1210comprises a valve body 1211 defining three ports, 1212, 1214, and 1216,in like manner to stopcock valve 1160 discussed previously. The firstport 1212 is fluidly coupled to the discharge conduit 1130 on thesyringe body 1122 of the syringe 1120 and this fluid coupling may be apermanent connection provided by an intermediate conduit element 1218that is bonded to the first port 1212 and to the discharge conduit 1130,for example, by a medical grade adhesive, solvent bonding, ultrasonicwelding, and like joining methods known in the medical field.Alternatively, a disconnecting connection or like connection may beprovided between the first port 1212 and the discharge conduit 1130, forexample, by a direct but disconnecting connection between the first port1212 and the discharge conduit 1130 or via a disconnecting intermediateconduit element similar to the illustrated intermediate conduit element1218 but having suitable connector ports. The second port 1214 isfluidly coupled to a conventional connector spike 1175 via connectingtubing 1174 in a similar manner to the previously discussed embodimentsof the fluid control valve 1150. The third port 1216 is provided with aconnector element 1220 similar to connector element 1206 describedpreviously in connection with the piston valve 1180 and the fluidconnector 1176 described previously in connection with the stopcockvalve 1160, and is adapted in like manner to connector elements 1206,1176 to interface with mating fluid connector(s) 1506 associated withthe single-use set 1500; the details for fluid connectors 1176, 1206,1220 and mating fluid connector 1506 may be found in United StatesPatent Application Publication No. 2008/0086087 and/or in United StatesPatent Application Publication No. 2005/0234428, both of which wereincorporated herein previously by reference. In view of the foregoing,it will be appreciated that fluid connectors 1176, 1206, 1220 areidentical fluid connectors but are given different reference numeralsfor identity with the respective embodiments of fluid control valve1150. In the illustrated embodiment, the connector element 1220comprises a connector conduit 1221 extending proximally from connectorelement 1220 to interface with the third or outlet port 1216 via aninterfacing bushing 1222. Ports 1212, 1214, and 1216 each interface viasnap-fit/friction-fit engagement with the respective attachment elements208 on the cover plate 206 of the fluid control module housing 202 ingenerally the same manner as described previously in connection with thestopcock valve 1160.

A first check valve 1224 is disposed in the second port 1214 of the dualcheck valve 1210. The first check valve 1224 comprises a unitaryconnector body 1226 having a first annular portion 1228 secured withinthe second port 1214, and a second annular portion 1230 wherein theconnecting tubing 1174 connected to connector spike 1175 is disposed andsecured. Securing of the first annular portion 1228 of the connectorbody 1226 within the second port 1214 and securing of the connectingtubing 1174 within the second annular portion 1230 of the connector body1226 may be by any of the conventional joining methods describedpreviously in this disclosure. A first check valve member 1232 isdisposed within the first annular portion 1228 of the connector body1226. Correspondingly, a second check valve 1234 is associated with thethird or outlet port 1216 of the dual check valve 1210. In particular,the second check valve 1234 comprises a second check valve member 1236seated within a first annular portion 1238 of the third port 1216. Thethird port 1216 further defines a second, larger annular portion 1240for interfacing with the connector conduit 1221 extending proximallyfrom the connector element 1220 via intermediate or intervening bushing1222. The bushing 1222 may further be used to maintain the positioningof the second check valve member 1236 within the first annular portion1238 of the third or outlet port 1216. The check valve members 1232,1236 are oppositely operable from one another so that the first checkvalve member 1232 permits fluid flow from a fluid source connected tothe connecting tubing 1174 via connector spike 1175 to enter the valvebody 1211 of the dual check valve 1210 but reverse flow into theconnecting tubing 1174 is prevented by the first check valve member1232, for example, when the syringe 1120 is operating to dispense orinject fluid via discharge conduit 1130. Similarly, the second checkvalve member 1236 is operable to permit fluid flow to enter the thirdport 1216 and the connector element 1220 and to pass to the single-useset 1500, but prevents reverse flow into the connector element 1220 fromthe single-use set 1500 and, particularly, any reverse flow from therespective input lines 1502, 1504 of the single-use set 1500 towardsyringe 1120.

A modified version multi-fluid medical injection/injector system 10 isshown in FIGS. 25-29, which will now be described. The modified versionof fluid injector system 10 comprises the same powered injector device20 and pressure jacket support 100 discussed previously but has certainmodifications to the fluid control module 200 and air detector module300 which results in certain modifications to the fluid delivery set1000. The present embodiment of the fluid injector system 10 comprises acombined fluid control module 200 and air detector module 300, whereinthe components of the previously discussed air detector module 300 areincorporated into the housing structure of the fluid control module 200.

With respect to the combined fluid control module 200 and air detectormodule 300 in the modified embodiment of the fluid injector system 10,the fluid control module 200 now generally comprises a pair of top andbottom cover plates 242, 244 between which the distal support flange 210extending from the front plate 112 of the pressure jacket support 100 issandwiched and secured in a similar manner to that described previouslyin this disclosure. Additionally, the depicted fluid control module 200comprises the same basic components as described previously, with thetop cover plate 242 comprising attachment points or elements 208 for therespective ports 1162, 1164, 1166 on stopcock valves 1160, similardetector sensors 232 as described previously and, moreover, similarcontrol valve actuators 220 as described previously. However, eachcontrol valve actuator 220 comprises its own actuator enclosure 246which is formed integrally with the bottom cover plate 244.

In the combined fluid control module 200 and air detector module 300,the top cover plate 242, the bottom cover plate 244, and the distalsupport flange 210 are elongated over the previously describedembodiment of the fluid control module 200 and, further, define frontslots or recesses 248 for receiving and supporting two pivotal airdetector assemblies 336 adapted for use with input lines 1502, 1504 ofsingle-use set 1500. As in the previously discussed embodiment of theair detector module 300, two front-located air detectors 320 areprovided in substantially the same location as described previously, forassociation with the respective connecting tubing lines 1174 used toconduct fluid from the fluid sources to the respective syringes 1120loaded in pressure jackets 136. These front-mounted air detectors 320may be supported between the top and bottom cover plates 242, 244 inlike manner to that described previously. The respective air detectorassemblies 336 are each comprised of an air detector 340 defining adetector recess 342 for receiving medical tubing associated with thesingle-use set 1500. Each air detector 340 is identical to air detectors320 described previously and is supported by a mounting element 344having a pair of tubing attachment elements 346 located on either sideof the detector recess 342 for receiving and securing medical tubing.Each mounting element 344 is connected to a pivotal support arm 348,pivotally secured within the respective front-located receivingslots/recesses 248.

The respective air detector assemblies 336 are pivotal in front slots orrecesses 248 from a position wherein the respective air detectors 340are generally horizontally aligned between the top cover plate 242 andbottom cover plate 244 to a pivoted position engaging one of the inputlines 1502, 1504 of single-use set 1500. The air detector assemblies 336are in a non-use position when the respective air detectors 340 aregenerally horizontally aligned or positioned in the respective front endslots or recesses 248. The use position of the air detector assemblies336 is defined when the respective air detector assemblies 336 arepivoted upward to define an upstanding, generally vertical orientationof the support arms 348 whereby the air detectors 340 may interface withthe input lines 1502, 1504 of the single-use set 1500.

The vertically-pivoted, use position of the air detector assemblies 336desirably provides an additional function in the present embodiment ofthe fluid injector system 10. In particular, in the vertically-pivoted,use position of the air detector assemblies 336, the attachment elements346 of mounting elements 344, which act as tubing securing elements orflanges, also secure the fluid connection between the single-use set1500 and the respective multi-use sets 1100 provided by an alternativefluid connector 1516 shown in detail in FIGS. 27-29. These fluidconnectors 1516 may be provided as an alternative to fluid connectors1506 described previously and are mounted to input lines 1502, 1504 and,further, are provided in place of the fluid connectors 1176 describedpreviously provided as part of the third or outlet port 1166 of therespective stopcock valves 1160 in the multi-use sets 1100.

Each fluid connector 1516 comprises a cylindrical body portion 1518having a closed bottom end 1520, an open top end 1522, and a side wall1524 defining a receiving bore or barrel 1526. A side port 1528 extendsfrom the side wall 1524 and is generally adapted to interface with thethird port 1166 of the stopcock valve 1160 in each of the multi-use sets1100. The side port 1528 may be configured, for example, for a matingconnection with the third or outlet port 1166 of a stopcock valve 1160.Alternatively, the side port 1528 may have a permanent connection to thethird port 1166 and, hence, be part of the stopcock valve 1160 in themulti-use sets 1100. A cap portion 1530 is adapted to cooperate with thecylindrical body portion 1518. The cap portion 1530 has a T-shapedconduit 1532 for fluid communication with the side port 1528. A top port1534 of the cap portion 1530 forms a connection port for connection tothe fluid lines 1502, 1504 of the single-use set 1500. The cap portion1530 may be provided as part of the single-use set 1500, with each fluidline 1502, 1504 carrying a cap portion 1530 in place of the fluidconnectors 1506 described previously. The cap portion 1530 comprises anelongated stem 1536 adapted for insertion into the barrel 1526 of thecylindrical body portion 1518. The stem 1536 defines a pair of annularreceiving recesses 1538 for accepting sealing O-rings 1540 so that agenerally fluid-tight seal may be established between the cap portion1530 and the cylindrical body portion 1518 when these components arejoined together. The cap portion 1530 is adapted for removable insertioninto the barrel 1526 of the cylindrical body portion 1518 and thisengagement is secured as described herein. A shoulder 1542 on the stem1536 has an outer diameter to fit snugly within the diameter of thebarrel or bore 1526 in the cylindrical body portion 1518. Further, thecap portion 1530 comprises an outward-extending radial flange 1544 whichis provided as a contact surface for interfacing with one of theattachment elements 346 on the mounting element 344 associated with theair detector 340 in each of the air detector assemblies 336 whichsecures the engagement between the cylindrical body portion 1518 and thecap portion 1530, as described herein.

Based on the foregoing, it will be appreciated that each input line1502, 1504 in single-use set 1500 is provided with a cap portion 1530adapted for fluid connection with a corresponding cylindrical bodyportion 1518 which is interfaced (either in a removable fashion or inpermanent connection) with the third port 1166 on a stopcock valve 1160in one of the multi-use sets 1100. Accordingly, to make the desiredfluid connections using the fluid connectors 1516 as shown in FIG. 25,the side port 1528 on the cylindrical body portion 1518 for each fluidconnector 1516 is placed in fluid connection or engagement with thecorresponding third port 1166 on one of the respective stopcock valves1160 of the multi-use sets 1100 and the cylindrical body portion 1518 issituated on the top cover plate 242. The top cover plate 242 is formedwith a pair of mounts 350 to provide a seating location for thecylindrical body portion 1518. The mounts 350 receive the cylindricalbody portion 1518 for each fluid connector 1516 once the side port 1528is inserted or otherwise associated with the corresponding third port1166 on the respective stopcock valves 1160. Alternatively, as describedin the foregoing, if the cylindrical body portion 1518 is connected tothe stopcock valve 1160 via permanent connection between the side port1528 and the third or outlet port 1166 on the stopcock valve 1160, theassociation of the stopcock valve 1160 with the attachment points orelements 208 on the cover plate 206 places the cylindrical body portion1518 in the corresponding receiving mount 350 on the cover plate 206.

Next, the cap portions 1530, which are connected to the respective inputlines 1502, 1504 of the single-use set 1500 via their respective topports 1534, are inserted into the barrel 1526 in the receivingcylindrical body portions 1518. Once these fluid connections are made,the corresponding pivotal support arm 348 may be pivoted upward to theuse position of the support arm 348, wherein the corresponding inputlines 1502, 1504 of the single-use set 1500 are received in operativeengagement with the air detector 340 supported by the respectivemounting elements 344 carried by the respective support arms 348 and theattachment elements 346 engage the tubing forming the correspondinginput lines 1502, 1504 to secure the tubing within the detector recess342 of the air detector 340. At the same time, the “lower” attachmentelement 346 on each mounting element 344 engages the top port 1534 onthe cap portion 1530 and, further, abuts against the contact surfacedefined by the radial flange 1544 extending about the cap portion 1530.With this contact engagement, the “lower” engaging attachment element346 secures the fluid connection between the cap portion 1530 and thecylindrical body portion 1518 in the respective fluid connectors 1516.

Referring further to FIGS. 30-32, it may be desirable to provideadditional or enhanced air injection protection in accordance with thisdisclosure by utilizing a downstream or secondary air detector module360 which is dedicated to the single-use set 1500. Secondary airdetector module 360 desirably includes a shut-off feature whereby,should air be detected in the tubing leading to the downstream shut-offor isolation stopcock 1512, this stopcock 1512 may be quickly andautomatically turned to a closed position to isolate the catheterconnector conduit 1514 and, thereby, shield a patient from a possibleair injection situation. Accordingly, air detector module 360 may beconsidered to be an air detector and protection module 360, (hereinafter“secondary air detector module 360”). Secondary air detector module 360comprises a module housing 362 comprising a depending actuator enclosure364 wherein a valve actuator 380 is disposed for controlled operation ofisolation stopcock 1512. A top cover or plate 366 encloses actuatorenclosure 364 and comprises a series of attachment points or elements368 for interfacing with the ports of the isolation stopcock 1512 tomechanically secure the isolation stopcock 1512 to the module housing304. This mechanical arrangement is similar to the way stopcock valve1160 interfaces with the cover plate 206 of fluid control module 200described previously.

Cover plate 306 and actuator enclosure 364 are connected in a removablefashion and, further, together enclose a supporting mounting plate 370to which valve actuator 380 is secured using conventional mechanicalfasteners 372. Valve actuator 380 is mechanically interfaced with asocket actuator element 382 via an output shaft 388 extending from thevalve actuator 380 to impart rotational motion to the socket actuatorelement 382. Socket actuator element 382 is configured to engage theactuation handle 1513 used to control operation of stopcock 1512 in asimilar manner to the way socket actuator element 222 associated withthe respective control valve actuators 220 interfaces with the actuationhandle 1170 of the stopcock valve 1160 described previously. Mountingplate 370 defines an aperture to allow passage of output shaft 388 forengaging socket actuator element 382 to operationally control theposition of the stopcock actuating handle 1513 and, thereby, theoperational position of isolation stopcock 1512. Generally, valveactuator 380 is adapted to selectively position the stopcock actuatinghandle 1513 in at least one of three positions, namely: (1) openposition, wherein fluid flow is permitted to catheter connector conduit1514 from port S.sub.1 of isolation stopcock 1512 to port S.sub.2 ofisolation stopcock 1512; (2) a closed or isolation position, wherein thecatheter connector conduit 1514 is isolated from upstream components(e.g., port S.sub.2 is blocked); and (3) a waste position, wherein awaste port W of isolation stopcock 1512 is open to allow draining offluid from single-use set 1500, if desired. In an exemplary embodiment,valve actuator 380 may be a DC brush motor or a stepper motor or likedevice to provide the motive forces for rotational movement of socketactuating element 382 and, thereby, cause operational movement of thestopcock actuation handle 1513.

Additionally, the secondary air detector module 360 comprises a pair ofair detectors 390 mounted to flanges 392 connected to the cover plate306. Air detectors 390 are similar to air detectors 320, 340 describedpreviously and are adapted to sense the presence of air in the tubingconnected to port S.sub.1 of isolation stopcock 1512 and in the tubingof catheter connector conduit 1514. Such an air detector arrangement onboth sides of isolation stopcock 1512 provides dual redundancy to theair protection function. Further, air detectors 390 are linked to theelectronic control device(s) associated with the injector 20 to provideinputs to the electronic control device(s) regarding the presence or airin proximity to isolation stopcock 1512 Likewise, valve actuator 380 iselectronically coupled to the electronic control device(s) so that,should the electronic control device(s) receive input(s) that air ispresent in proximity to the isolation stopcock 1512, the valve actuator380 may be controlled to place the isolation stopcock 1512 in the closedor isolation position discussed previously.

As described previously, loading of the respective multi-use sets 1100used with the injector 20 comprises inserting the respective syringes1120 into the corresponding pressure jackets 136 according to theloading steps described previously. The loading steps result in thedischarge outlet 1130 extending distally from the syringe body 1122 ofeach syringe 1120 being seated into the corresponding offset slot 122defined in the front plate 112 of the pressure jacket support 100.Likewise, the stopcock valve 1160 for each multi-use set 1100 isassociated with the fluid control module 200 in the manner describedpreviously, wherein the actuation handle 1170 of the respective stopcockvalves 1160 is mechanically interfaced with the socket actuator element222 of the corresponding or actuating control valve actuator 220 and sothat the respective ports 1162, 1164, and 1166 on the stopcock valves1160 are in engagement with the securing attachment elements 208provided on the cover plate 206 of the fluid control module housing 202.Each of the two multi-use sets 1100 used with the powered injector 20are loaded in a similar manner as described previously in thisdisclosure, which results in the syringes 1120 being loaded into thecorresponding pressure jackets 136 and the stopcock valves 1160 beinginterfaced and secured in an operable state with the fluid controlmodule 200.

Referring further to FIGS. 33-39, a generally horizontal orientation ofinjector 20, as shown in FIGS. 35A-35B, is believed to be the mostconvenient orientation to load the multi-use sets 1100 as described inthe foregoing. A generally horizontal orientation is a desirableposition for ergonomic reasons. A proximity sensor, such as a contactsensor or an optical sensor and the like, is used to determine whetherthe syringe plunger 1300 in the syringe body 1122 of each syringe 1120is in the correct position for engagement by the piston elements 60,desirably, in the storage/expansion section 1138 at the proximal end1126 of the syringe body 1122. If the syringe plungers 1300 are not solocated in the storage/expansion section 1138, this could indicate thatthe syringes 1120 are not new syringes 1120 but may have been usedpreviously, or that one or both of the syringes 1120 have been removedand brought back later for use as described pursuant to a possible“reuse-case” as set forth later in this disclosure. As a result, avisual or audible prompt may be provided by the electronic controldevice(s) in injector 20 to the attendant operator via the displaywindows 32 on the injector housing 22, and/or on a remote displaywindow, indicating that the syringes 1120 may have been used previouslyand are possibly unsterile. Such electronic control device(s) maydisable operation of the injector 20 until an override prompt or buttonis actuated by the attendant operator authorizing further use of thesyringes 1120. The electronic control device(s) may then cause thepiston elements 60 to extend forward or distally to fully capture thesyringe plungers 1300 in the syringe body 1122 of the respectivesyringes 1120 loaded into the receiving pressure jackets 136.Additionally, the detector sensors 232 described previously alsoidentify to the electronic control device(s) associated with injector 20that two multi-use sets 1100 are correctly interfaced with the fluidcontrol module 200 and pressure jackets 136. Further, the connectingtubing 1174 connected with the second port 1164 of each stopcock valve1160 is placed in operative association with the front-mounted airdetectors 320 of the air detector module 300. If desired, other fluiddelivery set 1000 installation steps may occur while the injector 20remains in a generally horizontal configuration such as interfacing thesingle-use set 1500 to the multi-use sets 1100, but this interfacingstep may more desirably be carried out during a later step as describedherein. The horizontal orientation of injector 20 is also believed to bethe best orientation to unload the multi-use sets 1100 when their usefullife is exhausted.

Once the multi-use sets 1100 have been installed, the electronic controldevice(s) associated with the injector 20 cause the piston elements 60to drive the captured syringe plungers 1300 distally forward to contactand seat against the conical distal end 1124 of the syringe body 1122.The connector spikes 1175 provided at the distal end of the connectingtubing 1174 and connected with the second port 1164 on each stopcockvalve 1160 of the two respective multi-use sets 1100 may then be placedin fluid connection with two fluid supply containers 36, 38, as shown inFIGS. 2-3, which may be like fluids or different fluids and, typically,comprise saline and radiographic contrast media. Once the foregoinginitial set-up sequence is completed, the injector 20 may be rotated toa fluid priming and air purge position to conduct a fluid priming andair purge procedure as discussed next in this disclosure.

In the fluid priming and air purge sequence, the injector 20 is pivotedabout pedestal support 90 to a purge position or orientation. Asdiscussed previously, pedestal support 90 comprises a support column 92for supporting the injector 20 adjacent a patient supporting surfacesuch as an examination table. As shown in FIGS. 38-39, the supportcolumn 92 may comprise a clamp 94 for attaching the support column 92 toa patient examination table or like surface having a rail for attachingequipment to the examination table. FIG. 38 shows that a storagecompartment 96 may be integrated with the support column 92 for storingancillary equipment associated with fluid injector system 10. A pivotjoint 98 is secured to the underside of the injector housing 22 andconnects the injector 20 to the support column 92. Electro-mechanicalcomponents reside in the injector housing 22 to effect operation of thepivot joint 98 to allow the injector 20 to exhibit pivoting movement onthe pedestal support 90. Alternatively, the injector 20 may be pivotedmanually if desired.

To reach the fill and purge position, the injector 20 pivots aboutpedestal support 90, typically in a direction away from the patientsupport surface (not shown), so that the discharge conduit 1130extending from the syringe body 1122 of each syringe 1120 loaded intothe respective pressure jackets 136 is positioned at the top of thesyringe body 1122 or at a high point for each loaded syringe 1120. Thepivoting movement of the injector 20 results in the injector 20“rolling” away from the patient support surface in the present scenario.With the syringes 1120 positioned with the discharge conduit 1130 oneach syringe body 1122 in a top position, any air bubbles remaining fromthe priming of the respective syringes 1120, as described herein, willbe present at the top of the syringe body 1122 of each syringe 1120 andin a position for easy viewing and purging from the syringe body 1122.Once the injector 20 is placed in the fluid priming and air purgeposition or orientation, the attendant operator may press the“Fill/Purge” hard-wired control button 34 on the injector 20 toautomatically fill the respective syringes 1120 with fluid and purge outair remaining in the syringe body 1122 of each syringe 1120. In anexemplary automated sequence for this cycle, once the attendant operatordepresses the “Fill/Purge” control button 34, the respective stopcockvalves 1160 in the multi-use sets 1100 open to a fill position whereinthe second port 1164 is in fluid connection with first port 1162 toallow filling of syringe 1120 via connector spike 1175 and connectingtubing 1174 associated with a fluid container, typically fluid supplycontainers 36, 38 as shown in FIGS. 2-3. In various embodiments shown inthe accompanying figures, the respective fluid supply containersdesirably contain contrast and saline so that different fluids areloaded into the respective syringes 1120. Such different fluids may becontrast and saline or, possibly, different concentrations of contrast,or possibly other types of fluid entirely, such as a radiopharmaceuticaldrug and saline.

Next, the electronic control device(s) associated with the injector 20actuates the piston elements 60 to retract the syringe plungers 1300seated within the syringe body 1122 of each syringe 1120 so that thesyringe plungers 1300 move proximally or rearward in the syringe body1122 of each syringe 1120. This proximal movement may continue until adesired amount of filling fluid is drawn into the syringe body 1122 ofeach syringe 1120 from the external fluid sources. In one non-limitingexample, the respective piston elements 60 move at 1 ml/s to introduceapproximately 15 ml of fluid and accompanying air into the respectivesyringes 1120. The piston elements 60 are then actuated by theelectronic control device(s) associated with injector 20 to movedistally or forward so that the syringe plunger 1300 in each syringebody 1122 moves distally or forward in the syringe body 1122 therebypurging air present in the syringe body 1122 back into the respectivefluid supply containers via the fluid path defined by stopcock valve1160, connecting tubing 1174, and connector spike 1175. Such air-purgingor forward movement may occur by the respective piston elements 60moving distally or forward at 5 ml/s until fluid is detected with airsensor 320, and then piston element 60 moves further forward the volumeof the disposable elements from the air sensor 320 to the tip of thespike 1175. The piston elements 60 are then actuated to reversedirection and move proximally or rearward, which causes the capturedsyringe plunger 1300 associated with each piston element 60 to moveproximally or rearward in the syringe body 1122 of each syringe 1120 tobegin filling the syringe body 1122 with fluid from the connected fluidsupply container 36, 38. This movement desirably continues until thesyringe body 1122 of each syringe 1120 is substantially filled withfluid to a desired level. Thereafter, the piston elements 60 areactuated to move forward a small amount, for example, to ejectapproximately 1.5 ml of fluid from the syringe body 1122 of each syringe1120 for slack correction purposes. The respective stopcock valves 1160in the multi-use sets 1100 are then operated by the electronic controldevice(s) associated with the injector 20 to the closed or isolationposition, wherein both the first and second ports 1162 and 1164 areisolated from the third or outlet port 1166.

To reach an injection position or orientation, the injector 20 ispivoted about pedestal support 90, but now in a direction toward thepatient support surface in the present scenario, so that the dischargeconduit 1130 extending from the syringe body 1122 of each syringe 1120loaded into the respective pressure jackets 136 is positioned on thebottom of the asymmetrical syringe body 1122. FIGS. 33-37 show thesequential movement of the injector 20 as it pivots from the fluidpriming and air purge orientation shown in FIG. 33 to the injectorientation shown in FIG. 37. To reach the injection position, thepivoting movement of injector 20 results in the injector 20 “rolling”toward the patient support surface in the present scenario and traversesapproximately 180.degree. of rotation. In the inject position, thedischarge conduit 1130 extending from the syringe body 1122 of eachsyringe 1120 is at the lowest point, making injection of air difficult.It is when the injector 20 is rotated to the inject position that it isdesirable to connect the single-use set 1500 to the respective multi-usesets 1100, which are operatively associated with the injector 20, fluidcontrol module 200, and air detector module 300. This connection stepgenerally includes connecting the respective input lines 1502, 1504 ofthe single-use set 1500 to the third or outlet ports 1166 of therespective stopcock valves 1160 in the multi-use sets 1100. Inparticular, the fluid connectors 1506 provided at the proximal end ofeach input line 1502, 1504 are joined to the mating fluid connector 1176on the outlet port 1166 of each stopcock valve 1160 in the respectivemulti-use sets 1100. Additionally, the input lines 1502, 1504 are placedin operative association with the top-located air detectors 320 on theair detector module 300 in the manner described previously. While thesingle-use set 1500 could potentially be connected to the multi-use sets1100 in the fluid priming and air purge position of the injector 20described previously, there is a possibility that the single-use set1500 may fall outside the sterile area surrounding the fluid injectorsystem 10 during the pivoting movement of the injector 20. It is notedthat the foregoing rolling motion of the injector 20 has distinctadvantages in that the fluid supply containers 36, 38 may be kept closeto the syringes 1120 thereby decreasing the tubing lengths between thefluid supply container 36, 38 and syringes 1120 and, as a result,decreasing the fill or refill time for the syringes 1120.

Once the single-use set 1500 is joined to the respective multi-use sets1100 and, further, associated with the appropriate air detectors 320 inthe air detector module 300, the single-use set 1500 is ready to beprimed with fluid and purged of air. The fluid priming and air purgingof the single-use set 1500 may include certain preliminary steps such asconnecting a pressure transducer (not shown) to the pressure isolationvalve 1510 and removing air from the pressure transducer and thepressure isolation valve 1510 via manual flush. To commence the fluidpriming and air purging of the single-use set 1500, the attendantoperator again presses the “Fill/Purge” control button 34. In anexemplary automated sequence for the fluid priming and air purging ofthe single-use set 1500, once the attendant operator depresses the“Fill/Purge” control button 34, the respective stopcock valves 1160 inthe multi-use sets 1100 move to an inject position, wherein the firstport 1162 of each stopcock valve 1160 is placed in fluid connection withthe third or outlet port 1166. The respective stopcock valves 1160 areeach placed in the foregoing inject position by the respective controlvalve actuators 220 which rotate the actuation handle 1170 of eachstopcock valve 1160 via the socket actuator element 222 so that theT-shaped passageway in the stopcock valves 1160 is in an orientationwhere the first and third ports 1162, 1166 are in fluid communication.The control valve actuators 220 are controlled by the electronic controldevice(s) associated with the injector 20 as described previously. Theelectronic control device(s) associated with the injector 20 furthercauses the piston elements 60 to move distally or forward whereby fluidfrom the respective syringes 1120 enters the single-use set 1500 and, inparticular, the respective input lines 1502, 1504. Movement of fluid inthe input lines 1502, 1504 continues until fluid in each line reaches apoint just distal or forward of Y-connector 1508. Typically, contrastand saline are respectively present in input lines 1502, 1504 (e.g.,each input line 1502, 1504 carries a different fluid therein). Once therespective fluids reach the point just distal or forward of theY-connector 1508, the stopcock valve 1160 fluidly coupled to the fluidsupply container 36, 38 containing contrast is operated to the closed orisolation position, wherein the first port 1162 is isolated from thethird or outlet port 1166. The stopcock valve 1160 that is fluidlycoupled to the saline fluid supply container 36, 38 desirably remains inan open or inject position and the associated syringe 1120 continues tosupply saline to the single-use set 1500 thereby priming the remainderof the downstream components of the single-use set 1500, namely, thepressure isolation valve 1510, isolation stopcock 1512, and catheterconnector conduit 1514 where the patient catheter is to be connected.Thereafter, the second “saline” stopcock valve 1160 is operated to aclosed position.

While the foregoing discussion identifies the steps used to initiallyprime the respective multi-use sets 1100 and single-use set 1500 withfluid and, further, purge air from the multi-use sets 1100, includingsyringes 1120, and from the single-use set 1500, it is desirable topermit refilling of the syringes 1120 during operation of fluid injectorsystem 10 so that the respective multi-use sets 1100 may be reusedtypically for a set number of uses and/or a set number of patients.Refilling of the syringes 1120 is often needed in practice because someinterventional procedures involving fluid injector system 10 can usemore contrast than is present in a single “charge” of contrast in onefilled syringe 1120 according to the foregoing discussion. In a refillsituation, it is desirable that refilling of one or both syringes 1120be done during a time that is convenient for the attendant operator ofthe fluid injector system 10. With the arrangement of the twin multi-usesets 1100 and single-use set 1500 and pivoting motion of the injector 20as described in the foregoing, the respective fluid supply containers36, 38 are always in close proximity to the discharge conduit 1130extending from the syringe body 1122 of each syringe 1120 and thelengths of medical tubing needed to conduct fluids to the syringes 1120may be made shorter. Thus, refill rates are faster. In particular, it isknown that for a given inner diameter (ID) tube, the shorter the lengthof tubing the faster the refill rate may be before vaporizing the fillliquid with a vacuum.

A standard refill method for syringes 1120 according to the presentdisclosure may include a hard-wired “Refill” control button 34 on theinjector 20 which the attendant operator depresses to cause refilling ofone or both of the syringes 1120. This functionality may also beincorporated into the graphical user interface (GUI) display windows 32on the injector 20, for example, as a user option on the graphical userinterface (GUI) display windows 32. Refill rate and volume to refill thesyringes 1120 may be preprogrammed by the attendant operator of thefluid injector system 10 as part of an initial data entry set-up for theelectronic control device(s) associated with injector 20, or bepreprogrammed into the electronic control device(s). The manual refillprocedure may be stopped either automatically by the electronic controldevice(s) according to a preprogrammed parameter or, alternatively, maybe interrupted by pressing the “Stop” control button 34 on the injector20 or by actuation of another device associated with the injector 20such as a hand controller (not shown) operatively connected to theinjector 20 and electronically coupled to the electronic controldevice(s).

The electronic control device(s) associated with injector 20 may also bepreprogrammed so that automatic refill occurs based upon a preprogrammedtrigger minimum volume in the respective syringes 1120. For example,when the volume of fluid remaining in (one or both of) the respectivesyringes 1120 is less than a programmed volume, a syringe refillprocedure is automatically initiated by the electronic controldevice(s). The electronic control device(s) associated with injector 20may determine that the preprogrammed trigger minimum volume has beenreached by tracking the fluid volume dispensed from the respectivesyringes 1120 during operation of the fluid injector system 10.Alternatively, optical fluid level sensors may be incorporated into thepressure jackets 136 supporting the respective syringes 1120 and inputsfrom these fluid level sensors may be provided to the electronic controldevice(s) so that the electronic control device(s) may determine whenthe preprogrammed trigger minimum volume has been reached in one or bothof the syringes 1120. The fill volume and rate of refill can bepreprogrammed in the electronic control device(s). The automatic refillprocedure can be stopped either automatically by the electronic controldevice(s) as described in the foregoing or may be manually interruptedby pressing the “Stop” control button 34 on the injector 20 or byactuation of another device associated with the injector 20 such as ahand controller (not shown) operatively connected to the injector 20. Inaddition, an automatic refill procedure may be initiated when, at thecompletion of a fluid injection procedure, there is not enough fluid inone or both syringes 1120 to perform the next programmed fluid injectionprocedure, for example, that the next preprogrammed injection volumeexceeds the actual volume in the syringe(s) 1120.

In a variation of the foregoing automatic refill procedure, theelectronic control device(s) associated with the injector 20 may includea timer and associated programming to initiate a refill procedure whenthe electronic control device(s) determines that a fluid injectionprocedure involving syringes 1120 is not likely to occur in the nearfuture. In other words, the programming of the electronic controldevice(s) desirably anticipates that inactivity of certain components ofthe fluid injector system 10 or certain states or conditions of thefluid injector system 10 indicate that a fluid injection procedure isnot likely to occur and automatic or “invisible” refilling of one orboth of the syringes 1120 may commence without interfering with animpending fluid injection procedure. For example, one triggering eventcould be the inactivity of a hand controller for a certain period oftime. Based on this inactivity, the electronic control device(s) maytrigger the automatic or “invisible” refill. In another example, aposition or orientation sensor, such as an accelerometer, in a handcontroller could identify to the electronic control device(s) that thehand controller has been set down; other possible sensor embodimentsinclude a capacitance touch sensor or thermal sensor. As with previousrefill procedures, once the foregoing refill procedure is commenced, thefill volume and refill rate can be based on preprogrammed parameters andinterruption of the refill procedure. The foregoing automatic or“invisible” refill procedure may also be interrupted by any of theinterrupt events discussed previously in this disclosure. Moreover,control of the foregoing automatic or “invisible” refill procedure maybe conducted by the electronic control device(s) associated with theinjector 20 such that when a fluid injection procedure is requested, theinjector 20 can transition so quickly from the refill procedure to thefluid injection procedure that the attendant operator would not perceivea time lag. This result may be accomplished by conducting the refillprocedure very slowly so as not to have to dissipate a vacuum whentransitioning to an inject state.

During a refill procedure, it is possible that one or both of the fluidsupply containers 36, 38 associated with the respective syringes 1120may become empty (e.g., initially lack sufficient fluid to complete afull refill of the syringes 1120). A replacement fluid supply container36, 38 is, therefore, necessary and replacement of such a fluid supplycontainer 36, 38 is desirably made quickly and without introducing airinto any components of fluid delivery set 1000. An exemplary procedurefor carrying out a fluid supply container change is as follows.Initially, a refill procedure has been triggered in some fashion, forexample, a manual, an automatic, or an automatic-invisible refillprocedure. Additionally, the stopcock valve 1160 associated with thesyringe 1120 requiring refilling is actuated to the fill positionwherein the second port 1164 is in fluid communication with the firstport 1162 to allow filling of the syringe 1120 via the connector spike1175 and connecting tubing 1174 associated with the present partiallyused fluid supply container 36, 38. The associated piston element 60interfaced with the syringe plunger 1300 in the syringe body 1122 of therefilling syringe 1120 moves proximally or rearward to begin refillingthe syringe 1120. As the fluid supply container 36, 38 empties of fluid,air is drawn into connecting tubing 1174 and, as this air column reachesthe in-line air detector 320 on the air detector module 300, the airdetector 320 alerts the electronic control device(s) associated with theinjector 20 which stops and reverses movement of the associated pistonelement 60 to push fluid back through the connecting tubing 1174 to theconnector spike 1175. The electronic control device(s) then actuates thestopcock valve 1160 to the closed or off position isolating the outletport 1166 from the first and second ports 1162, 1164. A prompt is givento the attendant operator via the graphical user interface (GUI) displaywindows 32 on the injector 20 to remove the fluid supply container 36,38 and spike a new fluid supply container 36, 38 with the connectorspike 1175. The electronic control device(s) then actuates the stopcockvalve 1160 to the fill position described previously and actuates theassociated piston element 60 engaged with the syringe plunger 1300 inthe syringe body 1122 of the refilling syringe 1120 to move forward asmall amount to purge any air remaining in the connector spike 1175 orconnecting tubing 1174. Refilling of the syringe 1120 then continuesaccording to the methodology described hereinabove.

An advantage of the multi-use sets 1100 described in this disclosure isthat each such set 1100 is easily removed from association with theinjector 20, fluid control module 200, and air detector module 300 sothat, for example, contrast media changes may be made for a singlepatient (intra-patient) or contrast media changes may easily be madebetween patients. Moreover, the multi-use sets 1100 described in thisdisclosure allow for removal of a used multi-use set 1100 and itstemporary storage for re-use, typically the same day, withoutcompromising sterility. In particular, a contrast-containing multi-useset 1100 and its associated fluid supply container 36, 38 containingcontrast media form a closed system which may be removed for temporarystorage with the only additional sterility protection required being asterile cap or cover used to enclose the fluid connector 1176 on thethird or outlet port 1166 of the stopcock valve 1160.

An exemplary procedure for removing, storing, and reusing a usedmulti-use set 1100 as described in the preceding paragraph will now bedescribed. In the following discussion, it is assumed that the currentpatient is finished with the current interventional study and, as aresult, the single-use set 1500 may be removed from connection with thedual multi-use sets 1100 and discarded as medical waste. Sterile caps,as noted in the foregoing, are added to the fluid connector 1176 on thethird or outlet port 1166 of the stopcock valve 1160 in each multi-useset 1100. The attendant operator then actuates the “Unload” controlbutton 34 on the injector 20. The “Unload” control button 34 then causesa sequence of actions to occur, as described herein, which permits bothmulti-use sets 1100 to be removed if desired. However, it may also bedesirable to provide two “Unload” control buttons 34, one for eachmulti-use set 1100, to allow removal of one or the other of themulti-use sets 1100 from the injector 20, for example, if it is desiredto remove the multi-use set 1100 containing contrast media while themulti-use set 1100 containing saline remains engaged with the injector20, fluid control module 200, and air detector module 300. The followingdiscussion describes the removal sequence for one multi-use set 1100 forexemplary purposes.

Once the “Unload” control button 34 is actuated, the control valveactuator 220 is controlled by the electronic control device(s)associated with the injector 20 to move the stopcock valve 1160 to thefill position described previously and then actuates the piston element60 engaged with the syringe plunger 1300 in the syringe body 1122 of thesyringe 1120 to move proximally or rearward to a storage position. Thestorage position of the piston element 60 corresponds to placement ofthe syringe plunger 1300 to a set position in the storage/expansionsection 1138 of the syringe body 1122 of the syringe 1120, and thisposition is typically a different axial position from a “new” syringe1120 with a factory-set axial position. The electronic control device(s)then causes the control valve actuator 220 to place the stopcock valve1160 in the closed or off position where the third or outlet port 1166is isolated from the first and second ports 1162, 1164. At this point,the stopcock valve 1160 may be disengaged from the attachment elements208 on the cover plate 206 of the fluid control module 200 and thecorresponding pressure jacket 136 may be pivoted upward in the mannerdescribed previously to permit removal of the syringe 1120 from thebarrel 162 of the pressure jacket 136. The syringe 1120, stopcock valve1160, and connector spike 1175 with attached connecting tubing 1174 arethen stored as one unit along with the fluid supply container 36, 38connected to the connector spike 1175.

As will be appreciated from the foregoing, each time a syringe 1120 isloaded into a pressure jacket 136 in the fluid injector system 10 andthe corresponding piston element 60 is extended to engage the syringeplunger 1300 in the syringe 1120, a determination may be made as towhether the syringe 1120 is an entirely new syringe 1120, meaning thatthe syringe 1120 has not been previously used, or is a previously usedsyringe 1120 and has been previously unloaded. The electronic controldevice(s) associated with the injector 20 can make this determinationvia a position or proximity sensor, for example, a contact or opticalsensor, integrated into piston elements 60 of the injector 20, which canprovide information to the electronic control device(s) as to theposition of the syringe plunger 1300 in the syringe body 1122 of thesyringe 1120. If the position of the syringe plunger 1300 corresponds toan initial position as set during manufacturing of the syringe 1120, theelectronic control device(s) determines the syringe 1120 is an unusedsyringe 1120. If the syringe plunger 1300 is located at the storageposition described previously arrived at as a result of a syringeunloading procedure, the electronic control device(s) determines thatthe syringe 1120 is a previously used syringe 1120 and fluid is mostlikely contained therein. It will be appreciated that the initial orfactory set position of the syringe plunger 1300 in the syringe body1122 of the syringe 1120 is also located within the storage/expansionsection 1138 of the syringe body 1122 but at a different axial locationfrom the storage position resulting from a syringe unloading procedure.

Initially, the injector 20 is pivoted on the pedestal support 90 to agenerally horizontal orientation as described previously and this stepis the same whether the syringe 1120 to be associated with the injector20 is a new syringe 1120 or a previously-used syringe 1120. The syringe1120 is then loaded into the receiving pressure jacket 136 and thestopcock valve 1160 of the multi-use set 1100 is physically interfacedwith the fluid control module 200 according to the methodology describedpreviously in this disclosure. The electronic control device(s)associated with the injector 20 then actuates the corresponding pistonelement 60 to move distally or forward until the syringe plunger 1300 inthe syringe body 1122 of the syringe 1120 is encountered via theproximity sensor on the piston element 60. A suitable proximity sensorfor this purpose is described in U.S. Pat. No. 7,018,363 (Cowan, et al.)and in United States Patent Application Publication Nos. 2004/0064041(Lazzaro et al.) and 2005/0113754 (Cowan), each of which was previouslyincorporated herein by reference. If it is determined that the syringe1120 has been previously used, the following exemplary procedure may beused to reload the syringe 1120 to the injector 20 and associate theother components of the multi-use set 1100 with the fluid control module200 and air detector module 300.

Once it is determined that the encountered syringe 1120 is apreviously-used syringe, the piston element 60 does not proceed to drivethe syringe plunger 1300 forward to a distal-most position in thesyringe body 1122 as described previously in connection with an entirelynew syringe 1120. In contrast, movement of the piston element 60 stopsupon interfacing engagement with the syringe plunger 1300. Theelectronic control device(s) associated with the injector 20 then causesthe injector 20 to pivot or roll to the fill and purge position (or anattendant operator does this step manually), as shown in FIGS. 33A-33B,which orients the offset discharge conduit 1130 on the syringe body 1122to a top or purge position. The attendant operator then actuates the“Purge” control button 34 and a prompt or other display is presented tothe attendant operator to manually control the piston element 60 to movethe piston element 60 forward. The stopcock valve 1160 is substantiallysimultaneously actuated by the electronic control device(s) to move tothe inject position so that an air purging step may occur. Visualdetection by the attendant operator helps ensure that no air is trappedin the syringe 1120. The stopcock valve 1160 is then actuated by theelectronic control device(s) to the fill position and the syringe 1120is then refilled according to the procedures outlined previously in thisdisclosure. If the syringe 1120 is entirely empty of fluid, which is onepossible state of the syringe 1120 in the unloading procedure discussedpreviously, the initial fill sequence described previously in connectionwith a new syringe 1120 may alternatively be followed to completely fillthe syringe 1120 with fluid, typically contrast media.

In the foregoing, single-use set 1500 was described generally andreference is made to certain United States and internationalpublications for details of the single-use set 1500. An improvement tothe single-use set 1500 is shown in FIGS. 40-43 and is generallydesignated with reference numeral 1600. When comparing single-use set1500 to single-use set 1600, generally the flow-based pressure isolationvalve 1510 is replaced with a pressure isolating stopcock assembly ordevice 1610, as described herein, which enhances air-purging operations,as air-purging of the associated pressure transducer (not shown) may bedone automatically. Additionally, air sensor(s) may be provided on adownstream side of the stopcock pressure isolation valve, and possiblyon the pressure isolation port itself on the stopcock for enhancedsafety purposes. Furthermore, the stopcock pressure isolation valve isdesirably made of hard plastic so that hemodynamic pressure signals arenot as attenuated as much as in a more compliant pressure isolationvalve. Moreover, positive closure features provided by the stopcockpressure isolation valve prevent cross contamination and densityexchange of fluids (e.g., contrast media and saline or blood in mostapplications). The foregoing advantages provided by single-use set 1600are exemplary and non-exhaustive.

Generally, multi-use sets 1100 remain unchanged from that describedpreviously in this disclosure with the addition of a Y-connector asdescribed herein. FIGS. 40-43 illustrate the respective stopcock valves1160 associated with the multi-use sets 1100 operationally interfacedwith fluid control module 200. However, connecting tubing 1174associated with the second port 1164 of each stopcock valve 1160 isomitted for clarity purposes in these figures. The pressure isolatingstopcock assembly or device 1610 comprises a control valve actuatordevice 1612 that is supported from the distal or front end of the fluidcontrol module housing 202 via a pair of support arms in a mannersimilar to the way air detector module 300 is supported to the fluidcontrol module housing 202. The control valve actuator device 1612(hereinafter “actuator device 1612”) is generally similar to the controlvalve actuators 220 described previously. The actuator device 1612comprises an interfacing actuator element 1614 and attachment points orelements 1616. A pressure isolating stopcock 1620 mechanicallyinterfaces with the actuator element 1614 via an actuation handle 1621and is secured to the actuator device 1612 via the attachment elements1616 in a similar manner to the mechanical interfacing of stopcockvalves 1160 with the actuator elements 222 and attachment elements 208of fluid control module 200 described previously. Accordingly, thepressure isolating stopcock 1620 is an automated stopcock valve operablebetween several positions or states in a similar manner to the operationof the stopcock valves 1160 described previously. Operation of theactuator device 1612 is desirably effected by the electronic controldevice(s) associated with injector 20. The operational states of thepressure isolating stopcock 1620 are described herein.

The pressure isolating stopcock 1620 is generally a three-positionautomated stopcock valve comprising a first or inlet port 1622, a secondor outlet port 1624, and a third or pressure isolating port 1626 towhich a pressure transducer T to be fluidly isolated from high pressureflows is connected. The pressure transducer T may be mounted to a heightadjusting pole to align with a patient's chest cavity. The first orinlet port 1622 is connected via Y-connector conduit 1628 to therespective third outlet ports 1166 of stopcock valves 1160. Y-connectorconduit comprises a Y-connector with a distal fluid connector 1630adapted to interface with the first or inlet port 1622. The first orinlet port 1622 and distal fluid connector 1630 may have a similarmating configuration to mating fluid connectors 1176, 1516 describedpreviously, or may be standard luer connections as is well-known in themedical field. Y-connector conduit 1628 also comprises proximal fluidconnectors 1632 adapted to fluidly couple to fluid connectors 1176provided on the third or outlet ports 1166 of the stopcock valves 1160of the multi-use sets 1100 and, therefore, may have specific matingconnections for interfacing with the fluid connectors 1176 or,alternatively, may be standard luer connections as is well-known in themedical field. With the Y-connector conduit 1628 in place, mixing offluids in the single-use set 1600 is accomplished just prior to thepressure isolating stopcock 1620. While Y-connector conduit 1628 may beprovided as part of the single-use set 1600, it may also be provided aspart of the multi-use set 1100 described previously as desired. If theY-connector conduit 1628 is provided as part of the multi-use sets 1100,the sterility break or connection point resides at the distal fluidconnector 1630. If the Y-connector conduit 1628 is provided as part ofthe single-use set 1600, the sterility break or connection point residesat the proximal fluid connectors 1632. An outlet catheter connector 1634is fluidly coupled to the second or outlet port 1624 of the pressureisolating stopcock 1620.

In the foregoing fluid connections, it may be desirable to form theconnections between the third or pressure isolating port 1626 and thepressure transducer T and between the second or outlet port 1624 and thecatheter connector conduit 1634 as integral or permanent connections viaany of the suitable joining techniques described previously. Typically,the connection between the first or inlet port 1622 and the Y-connectorconduit 1628 is detachable in accordance with this disclosure for thereasons detailed previously. Accordingly, the single-use set 1600generally comprises the pressure isolating stopcock 1620, the catheterconnector conduit 1634, optionally the pressure transducer T, and,optionally, includes Y-connector conduit 1628. If desired, theconnections between the third or pressure isolating port 1626 and thepressure transducer T and between the second or outlet port 1624 andcatheter connector conduit 1634 may also be detachable connections asprovided, for example, via interfacing luer connections as is well-knownin the medical field.

An air detector 1640 is mounted to the actuator device 1612 to interfacewith the catheter connector conduit 1634 connected to the second oroutlet port 1624 of the pressure isolating stopcock 1620. Air detector1640 is interfaced with the electronic control device(s) associated withinjector 20 to identify the presence of air in the catheter connectorconduit 1634. The actuator device 1612 or, optionally, the air detector1640 comprises a detector sensor to identify the presence of thepressure isolating stopcock 1620 and such a detector sensor may beincorporated into actuator device 1612 in a similar manner to detectorsensors 232 associated with the fluid control module 200 describedpreviously. Alternatively, such a detector sensor may simply determinewhether the catheter connector conduit 1634 is associated with the airdetector 1640. A downstream isolation stopcock valve 1642 may beprovided as part of catheter connector conduit 1634 and provide similarpatient-isolating, waste-dumping, air aspiration, or, possibly, druginjection functions to stopcock valve 1512 described previously. It willbe appreciated that any of the various features and attributes describedpreviously in connection with the stopcock valve 1512 may be applied tostopcock valve 1642, such as interfacing with the second or downstreamair detector module 360 with the stopcock 1642.

With the various features of single-use set 1600 now described,exemplary operational use of single-use set 1600 will now be set forth.In use during a fluid delivery or injection procedure, pressureisolating stopcock 1620 is engaged with the actuator device 1612 withthe actuation handle 1621 in operative engagement with the actuatorelement 1614 whereby operation of the actuation handle 1621 may placethe first or inlet port 1622 in fluid communication with the second oroutlet port 1624. Fluid flow entering the pressure isolating stopcock1620 may pass to the catheter connector conduit 1634 and, ultimately, apatient catheter connected to the catheter connector conduit 1634, whilethe pressure isolating port 1626 and the pressure transducer T connectedthereto are isolated from any pressurized fluid flow in the stopcock1620. If an arterial or venous blood pressure reading is desired,pressure isolating stopcock 1620 may be operated via the electroniccontrol device(s) associated with injector 20 to place the pressureisolation port 1626 in fluid communication with the second or outletport 1624 and, thereby, allow blood vessel pressure measurements to betaken. Moreover, the pressure isolating stopcock 1620 may be operated soas to place the third or pressure isolation port 1626 in fluidcommunication with the first or inlet port 1622 so that air residing inthe tubing connected to the pressure transducer T may be purged. Thedownstream stopcock 1642 comprises a rotating catheter connection port1644 for connecting to a patient catheter (not shown) and a side port1646 that can perform several functions including as a waste port (e.g.,aspiration port), drug injection port, etc.

An exemplary air-purging procedure for the single-use set 1600 nowfollows. The following discussion generally assumes that the single-useset 1600 is interfaced with the multi-use sets 1100 according to theforegoing discussion, and that the respective multi-use sets 1100 havebeen purged of air according to the techniques described previously.With the injector 20 in an “inject” position, the distal end of thepressure transducer T is placed or maintained in an open state, open toatmospheric pressure and the pressure isolating stopcock 1620 is in astate or position where fluid communication is present between the firstor inlet port 1622 and the third or isolation port 1626. The injector 20is activated to “push” a desired fluid, typically saline, from one ofthe corresponding multi-use sets 1100 into the single-use set 1600,whereby the flushing fluid passes through the pressure isolatingstopcock 1620 and into the tubing connected to the pressure transducer Tand out through the pressure transducer T. The attendant operator, onceconfirming that fluid has passed out from the pressure transducer T,then stops further injection of flushing fluid from injector 20. Theelectronic control device(s) associated with the injector 20 thenoperates the pressure isolating stopcock 1620 into the inject position,wherein the first or inlet port 1622 and second or outlet port 1624 arein fluid communication and the injector 20 is again actuated to injectthe second fluid, typically contrast media, associated with the secondmulti-use set 1100 so that a volume of fluid equivalent to thevolumetric capacity of the second multi-use set 1100 passes through thefirst or inlet port 1622 of the pressure isolating stopcock 1620 (e.g.,past the first port 1622). This second injection procedure is ceased andthe injector 20 recommences pushing of flushing fluid via the firstmulti-use set 1100 and pushes a volume of fluid equivalent to thevolumetric capacity of the single-use set 1600. The air detector 1640provides confirmation when the last air bubble or volume from thecontrast-filling procedure passes into the single-use set 1600 and,therefore, “pushing” a volume of flushing fluid equivalent to thevolumetric capacity of the single-use set 1600 is sufficient to purgeair entirely from the single-use set 1600.

Referring next to FIGS. 44-48, this disclosure now sets forth severalimplementations for detachably joining or interfacing a syringe plunger1300 disposed within the syringe body 1122 of a syringe 1120 to one ofthe piston elements 60 associated with injector 20. These severalimplementations are set forth hereinafter and any one of the followingimplementations may be utilized in accordance with this disclosure influid injector system 10. FIGS. 44A-44I show a first implementationwherein a hook-type interface is generally provided between the syringeplunger 1300 and piston element 60. Initially, it is noted that syringeplunger 1300 generally comprises a plunger element 1302 surrounded by anelastomeric cover 1304 defining a plurality of circumferential sealingribs 1306. In the hook-interface embodiment, plunger element 1302 isdesirably solid and comprises a tapered distal portion or end 1308 whichis seated within a tapered cavity 1310 in cover 1304 and an external orrear flange portion 1312 which seats against a proximal end of the cover1304. A circumferential recess 1314 is defined between and separates thetapered distal portion or end 1308 and the external or flange portion1312 wherein an inward extending radial rib 1316 of the cover 1304 isseated and secured to secure the engagement between the plunger element1302 and cover 1304. A proximal or rear hook element 1320 extendsproximally or rearward from the flange portion 1312 of the plungerelement 1302, with hook element 1320 defining a hook interface recess1322 inward from a hook tip 1330.

The opposing piston element 60 is adapted for engagement with the hookelement 1320 on the plunger element 1302 as now described. Pistonelement 60 generally comprises a ball screw shaft 600 surrounded by anouter sleeve 602 as is conventional in the powered medical injectorfield. A plunger interface element 604 is secured via a mechanicalfastener 606 to the outer sleeve 602. The plunger interface element 604defines an internal cavity 608 facing a distal end 610 of ball screwshaft 600 and, wherein, a proximity sensor 612 is disposed. Proximitysensor 612 is provided to identify the axial location of the syringeplunger 1300 within the syringe body 1122 of the syringe 1120 and, asdiscussed previously, may be a physical contact sensor, optical sensor,and like proximity sensors. As described previously, the proximitysensor 612 can provide information to the electronic control device(s)as to the position of the syringe plunger 1300 in the syringe body 1122of the syringe 1120. If the position of the syringe plunger 1300corresponds to an initial position as set during manufacturing of thesyringe 1120, the electronic control device(s) determines the syringe1120 is an unused syringe 1120. If the syringe plunger 1300 is locatedat the storage position described previously arrived at as a result of asyringe unloading procedure, the electronic control device(s) determinesthat the syringe 1120 is a previously used syringe 1120.

The plunger interface element 604 comprises a side plate 616 which maybe integrally formed therewith. A pivotal hook element 620 is pivotallyconnected to the side plate 616 at a pivot point 622 and a compressionspring 624 acts on the pivotal hook element 620. Compression or backingspring 624 is secured in opposing recesses 626, 628 defined,respectively, in the plunger interface element 604 and the hook element620; the opposing ends of backing spring 624 may be secured in theopposing recesses 626, 628 by conventional methods. A sealing skirt 629may be provided around the outer sleeve 602 of the piston element 60 andsecured in a recess or cavity in the rear plate 102 of the pressurejacket support 100 for sterility purposes. The hook element 620 has ahook tip 630.

With the respective interfacing components of the syringe plunger 1300and piston element 60 now set forth for the depicted hook interfaceimplementation used to interface the syringe plunger 1300 and pistonelement 60, the operational sequence for the hook interfaceimplementation will now be described. FIG. 44A illustrates the initialloading of the syringe 1120 into pressure jacket 136 wherein the syringe1120 is received into the barrel 162 of the pressure jacket 136.Insertion of the syringe 1120 is generally complete with the engagementof the key elements 1144 in the keyway 158 defined in the inner surface160 of the body portion 152 of the pressure jacket 136 as this limitsinsertion of syringe body 1122 into the pressure jacket 136, asdescribed previously. As the pressure jacket 136 is pivoted downward inthe manner described previously, the hook tip 630 on the hook element620 is disposed in the hook recess 1322 defined by the hook element 1320extending proximally from the plunger element 1302 of the syringeplunger 1300, as shown in FIG. 44C. Backing spring 624 maintains thisarrangement by providing a backing force against the hook element 1320.A small space or clearance is defined between the hook tip 1330 of thehook element 1320 and the hook tip 630 of the hook element 620 to permitinter-engagement between hook elements 1320, 620. With the hookinterface between the syringe plunger 1300 and piston element 60 nowformed, movement of the piston element 60 in a distal or forwarddirection imparts linear movement to the syringe plunger 1300. Inparticular, as the piston element 60 moves in a distal or forwarddirection, as shown between FIG. 44C and FIG. 44D, the side plate 616contacts the rear flange portion 1312 of the plunger element 1302 andthis contact engagement imparts distal or forward movement to thesyringe plunger 1300. If the piston element 60 moves in a proximal orrearward direction, as shown in FIG. 44E and FIG. 44F, hook element 620contacts and engages the opposing hook element 1320 extending from therear flange portion 1312 of the plunger element 1302 and thisinter-engagement imparts proximal or rearward movement to the syringeplunger 1300, with the inter-engagement of the respective hooks 620,1320 being maintained by backing spring 624.

FIGS. 44G-44I, illustrate the unloading sequence for the syringe 1120when removing the syringe 1120 from the receiving pressure jacket 136,and this sequence just reverses the sequence described in the foregoingfor loading the syringe 1120 into the pressure jacket 136. In theremoval sequence, a small space or clearance is again defined betweenthe hook tip 1330 of the hook element 1320 and the hook tip 630 of thehook element 620 to permit pivotal disengagement between hook elements1320, 620. In particular, if it is desired to release the interferenceengagement between the syringe plunger 1300 and piston element 60, thesyringe plunger 1300 is first retracted to the storage position by thepiston element 60 which corresponds to placement of the syringe plunger1300 in the storage/expansion section 1138 of the syringe body 1122 ofthe syringe 1120 as described previously. In this position, the pistonelement 60 is withdrawn so that the plunger interface element 604 ispositioned generally within the front opening 110 in the rear plate 102of pressure jacket support 100. The small spacing between the hook tip1330 of the hook element 1320 and the hook tip 630 of the hook element620 is formed by a small distal or forward movement of the pistonelement 60, which remains generally within the front opening 110. Oncethe small space or clearance is defined between the hook tip 1330 of thehook element 1320 and the hook tip 630 of the hook element 620, thepressure jacket 136 may be pivoted upward as shown in FIGS. 44H-44Iwhich pivotally disengages the hook elements 1320, 620 from one anotherand the syringe 1120 may be removed from the pressure jacket 136.

Another syringe plunger 1300 and piston element 60 interfacingarrangement is discussed hereinafter with reference to FIGS. 45A-45H,wherein like elements are identified with like reference numerals asused in the foregoing description of FIGS. 44A-44I. In FIGS. 45A-45H, arotational piston interfacing arrangement is used to form the mechanicalinterface between the syringe plunger 1300 and piston element 60. Inthis embodiment, the plunger element 1302 is a hollow element defining areceiving cavity or bore 1340 and the rear flange portion 1312 definesan inward extending radial rib or rim 1342 at a proximal end forinterfacing with piston element 60. Proximal radial rib or rim 1342 isformed on the rear flange portion 1312 of the plunger element 1302 whichdefines an annular recess 1344. The tapered distal end 1308 of plungerelement 1302 may define openings 1346 therein as illustrated but mayalso be an entirely closed end wall as well. The radial rib or rim 1342on rear flange portion 1312 defines a pair of opposed keyways or slots1348, as shown in FIG. 45D and FIG. 45F, to allow access of elementsassociated with the piston element 60 into the receiving cavity or bore1340.

Opposing piston element 60 in the present embodiment comprises an innersleeve 632 that is disposed within the outer sleeve 602 and is furtherdisposed about the ball screw shaft 600. The outer sleeve 602 and innersleeve 632 are secured together to form a unitary device or componentand, alternatively, may be formed as a single unitary structure ifdesired. A plunger interface element 634 is supported by the outer andinner sleeves 602, 632. The inner sleeve 632 defines an internalcompartment or cavity 636 housing a motor 638 which is secured to theinner sleeve 632 via a motor mounting plate 640. An output shaft 642from the motor 638 is mechanically interfaced with the plunger interfaceelement 634 and is used to impart rotational movement to the plungerinterface element 634. The plunger interface element 634 comprises apiston stem 644 defining a bore 646 wherein the motor output shaft 642is disposed and in interference engagement with the plunger interfaceelement 634 so that rotational motion of the motor output shaft 642 isimparted to the plunger interface element 634. The plunger interfaceelement 634 comprises a pair of key or tab elements 648 for interfacingwith the proximal radial rim 1342 provided on the rear flange portion1312 of the plunger element 1302.

The operational sequence for interfacing the syringe plunger 1300 andpiston element 60 begins in FIG. 45A which illustrates thefully-inserted position of the syringe 1120 in the receiving pressurejacket 136 and the pressure jacket 136 pivoted to a horizontalorientation. The loading steps for loading the syringe 1120 in thepressure jacket 136 are omitted but are similar to that described inconnection with FIGS. 44A-44I, discussed previously. As shown in FIG.45A, the piston stem 644 is spaced a distance from the rear flangeportion 1312 of the plunger element 1302 but generally aligned with thereceiving cavity or bore 1340 in the plunger element 1302. Theorientation of the syringe plunger 1300 is such that the keyways 1348 inthe radial rim 1342 on the rear flange portion 1312 are aligned with theopposed key or tab elements 648 on the piston stem 644. Accordingly, anydistal or forward movement of the piston element 60 allows the keyelements 648 to enter the receiving cavity or bore 1340 in the plungerelement 1302 via the keyways 1348. Distal or forward movement of thepiston element 60 is shown in FIGS. 45A-45C and the correspondingpassage of the key elements 648 in keyways 1348 is shown in FIG. 45D.The distal or forward movement of the piston element 60 results in thepiston stem 644 being received in the receiving cavity or bore 1340 inplunger element 1302. With the piston stem 644 extending into thereceiving cavity or bore 1340 in the plunger element 1302, any distal orforward movement of the piston element 60 automatically imparts distalor forward motion to the syringe plunger 1300 by contact engagementbetween a distal end or face 650 of the outer sleeve 602 and the rearflange portion 1312 of the plunger element 1302.

Referring in particular to FIGS. 44E-44G, it will be appreciated that tocause proximal or rearward movement of the syringe plunger 1300 in thesyringe body 1122 of the syringe 1120, an interference engagementbetween the syringe plunger 1300 and piston element 60 is required. Toform the interference engagement between the syringe plunger 1300 andpiston element 60, motor 638 is operated to rotate the motor outputshaft 642 which causes the plunger interface element 634 to likewiserotate. The rotational movement imparted to the plunger interfaceelement 634 is on the order of about 90.degree., whereby the keyelements 648 on the piston stem 644 are oriented approximatelyorthogonal to the keyways 1348 in the radial rim 1342 in the rear flangeportion 1312 of the plunger element 1302. Thus, the key elements 648 areplaced in interference engagement with the radial rim 1342 on the rearflange portion 1312 of the plunger element 1302. The interferenceengagement between the key elements 648 and the radial rib 1342 on therear flange portion 1312 of the plunger element 1302 may be established,if desired, immediately after the key elements 648 enter the receivingcavity or bore 1340 in the plunger element 1302 via keyways 1348 tothereby provide the interference engagement between the syringe plunger1300 and piston element 60. Alternatively, the interference engagementmay be established when the piston element 60 is directed to move inreverse or proximal direction by the electronic control device(s)associated with the injector 20. While rotational movement of theplunger interface element 634 of about 90.degree. is described in theforegoing as desirable, this is intended to be only exemplary and anyrotational movement of plunger interface element 634 that places the keyelements 648 in interference engagement with the radial rim 1342 on therear flange portion 1312 of the plunger element 1302 is sufficient inaccordance with this disclosure. With the interference engagementestablished between the key elements 648 and the radial rim 1342 on therear flange portion 1312 of the plunger element 1302, proximal orrearward movement of the piston element 60 causes the syringe plunger1300 to withdraw or move proximally or rearward in the syringe body 1122of the syringe 1120.

When it is desired to release the interference engagement between thesyringe plunger 1300 and piston element 60, the syringe plunger 1300 isreturned to the storage position by the piston element 60 whichcorresponds to placement of the syringe plunger 1300 in thestorage/expansion section 1138 of the syringe body 1122 of the syringe1120 as described previously. The motor 638 is then operated to rotatethe motor output shaft 642 which causes the plunger interface element634 to likewise rotate. The rotational movement imparted to the plungerinterface element 634 is again on the order of about 90.degree. (ineither direction), whereby the key elements 648 on the piston stem 644are oriented approximately in alignment with the keyways 1348 in theradial rim 1342 on the rear flange portion 1312 of the plunger element1302. Thus, the key elements 648 are placed in an orientation to beremoved of interference engagement with the radial rim 1342 in the rearflange portion 1312 of the plunger element 1302. Proximal or rearwardmovement of the piston element 60 withdraws plunger interface element634 from engagement with the plunger element 1302 and the plungerinterface element 634 may be withdrawn into the front opening 110 in therear plate 102 of the pressure jacket support 100. Thereafter, thepressure jacket 136 may be pivoted upward to a removal orientation forremoving the syringe 1120 from the barrel 162 of the pressure jacket 136according to the unloading procedure set forth previously in thisdisclosure.

A further syringe plunger 1300 and piston element 60 interfacingarrangement is discussed hereinafter with reference to FIGS. 46A-46I,wherein like elements are identified with like reference numerals asused in the foregoing description of the previous embodiments of thesyringe plunger 1300 and piston element 60 interfacing arrangements. Inthe present embodiment, a cam interfacing arrangement is used to formthe mechanical interface between the syringe plunger 1300 and pistonelement 60. In this embodiment, the plunger element 1302 is again ahollow element defining a receiving cavity or bore 1340. However,whereas the rotational piston interfacing arrangement comprised the rearflange portion 1312 having an inward extending radial rib or rim 1342for interfacing with the piston element 60, such an interfacing radialrib 1352 is now formed within the receiving cavity or bore 1340 and partof the distal end portion 1308. The radial rib 1352 defines a distalannular recess 1354 in cavity or bore 1340. Additionally, in contrast tothe rotational piston interfacing arrangement, the interfacing radialrib or rim 1352 in the receiving cavity or bore 1340 does not define theopposed keyways or slots 1348 described previously but is instead acircumferentially extending radial rib or rim.

Opposing piston element 60 in the present embodiment comprises an outersleeve 602 as in previous embodiments and comprises a plunger interfaceelement 654 that is supported to a distal end of the outer sleeve 602.The plunger interface element 654 may be fixed to the distal end of theouter sleeve 602 by any suitable joining method including mechanicalfastening, friction fit engagement, or possibly via use of an adhesive.Outer sleeve 602 defines an internal compartment or cavity 656 housing asolenoid 658 which is secured within the compartment 656 via mechanicalfastening, friction fit engagement, or possibly via use of an adhesiveto maintain the positioning of the solenoid 658 in the sleevecompartment 656. An output shaft 662 extends from the solenoid 658 tomechanically interface with the plunger interface element 654. Theplunger interface element 654 comprises a piston stem 664 defining abore 666 wherein the solenoid output shaft 662 is disposed and inmechanical engagement with a cam element 668 so that rotational motionof the solenoid output shaft 662 is imparted to the cam element 668. Ahollow cap or end element 670 is disposed at the distal end of theplunger interface element 654 to enclose an open distal end of thepiston stem 664. Cap element 670 defines a hollow cavity 672 therein andsupports a pair of outward or radially extendable slide arms 674 in apair of opposed apertures 676 in the cap element 670. A torsion spring678 is also disposed in the hollow cavity 672 defined by the cap element670 and is engaged with the respective slide arms 674. The torsionspring 678 is held fixed in the cap element 670 and acts to maintain theslide arms 674 in a retracted position within the hollow cavity 672.Each slide arm 674 comprises a first end 680 disposed in the respectiveopposed apertures 676 and a second end 682 extending interiorly into thehollow cavity 672 defined by the cap element 670. The torsion spring 678acts upon the respective slide arms 674 so that the first end 680 ofeach of the slide arms 674 is positioned in the corresponding receivingaperture 676 to be generally flush with an exterior surface 684 ofpiston stem 664 (e.g., a retracted position). As further shown, the camelement 668 is operatively engaged with the second end 682 of each ofthe slide arms 674 within the hollow cavity 672 defined by cap element670. The plunger interface element 654 further comprises a shoulder orflange 686 formed proximally of the piston stem 664 which is inengagement with an open distal end 688 in outer sleeve 602 to enclosethe sleeve compartment 656 defined within the outer sleeve 602. Theshoulder or flange 686 may be formed integrally with the piston stem 664and is secured in the open distal end 688 in the outer sleeve 602 viamechanical fastening, interference engagement, adhesive engagement, andlike methods.

Referring in particular to FIG. 46A, this figure shows the pressurejacket 136 pivoted to a horizontal orientation and the syringe 1120loaded therein ready for interfacing with piston element 60.Accordingly, the loading steps for loading syringe 1120 into pressurejacket 136 are again omitted in FIGS. 46A-46I, but follow the samemethodology as described previously in this disclosure. As FIG. 46Ashows, the piston stem 664 is spaced proximally from the syringe plunger1300 and proximal of the rear flange portion 1312 of the plunger element1302 of the syringe plunger 1300 but generally aligned with thereceiving cavity or bore 1340 in the plunger element 1302. In thepresent embodiment, the orientation of syringe plunger 1300 is not aconcern as in the previous embodiment described hereinabove. Distal orforward movement of piston element 60 allows the piston stem 664 toenter the receiving cavity or bore 1340 in the plunger element 1302. Aswill be appreciated, an outer diameter of the piston stem 664 is lessthan an inner diameter of the interfacing radial rim 1352 in thereceiving cavity or bore 1340 of the plunger element 1302. Accordingly,distal or forward motion of the piston element 60 causes the piston stem664 to enter the receiving cavity or bore 1340 until, desirably, the capelement 670 makes contact or is in close proximity with the plungercover 1304. At this location, the slide arms 674 associated with capelement 670 are located distally forward of the radial rim 1352 andcoextensive with the annular recess 1354. Moreover, with the piston stem664 extending into the receiving cavity or bore 1340 in the plungerelement 1302, any distal or forward motion of the piston element 60automatically imparts distal or forward motion to the syringe plunger1300 by contact engagement between the shoulder or flange 686 associatedwith the piston stem 664 and the rear flange portion 1312 of the plungerelement 1302.

Referring in particular to FIGS. 46E-46G, as with the rotational pistoninterface arrangement discussed previously, to cause proximal orrearward movement of syringe plunger 1300 in the syringe body 1122 ofthe syringe 1120, an interference engagement between the syringe plunger1300 and piston element 60 is required. To form the interferenceengagement between the syringe plunger 1300 and piston element 60,solenoid 658 is operated to rotate solenoid output shaft 662 whichcauses the cam element 668 to rotate and act upon slide arms 674; thisrotated position of the cam element 668 is shown in FIG. 46F and thecorresponding position of the slide arms 674 is also shown. Therotational movement of the cam element 668 causes radial movement of theslide arms 674 so that the slide arms 674 enter annular recess 1354defined distally forward of the radial rim 1352. As a result, the slidearms 674 are placed in interference engagement with the radial rib orrim 1352 within receiving cavity or bore 1340. This interferenceengagement between the slide arms 674 and the radial rim 1352 withinreceiving cavity or bore 1340 may be established, if desired,immediately after the piston stem 664 fully enters the receiving cavityor bore 1340 and either contacts or comes into close proximity to theplunger cover 1304. Alternatively, the interference engagement may beestablished when the piston element 60 is directed to move in reverse orproximal direction by the electronic control device(s) associated withthe injector 20. With the requisite interference engagement establishedbetween the slide arms 674 and the radial rim 1352 within the receivingcavity or bore 1340 in the plunger element 1302, proximal or rearwardmovement of the piston element 60 causes the syringe plunger 1300 towithdraw or move proximally or rearward in the syringe body 1122 of thesyringe 1120.

If it is desired to release the interference engagement between thesyringe plunger 1300 and piston element 60, the syringe plunger 1300 isdesirably returned to the storage position by the piston element 60which corresponds to placement of the syringe plunger 1300 in thestorage/expansion section 1138 of the syringe body 1122 of the syringe1120 as described previously. The solenoid 658 is then de-energizedwhich allows the torsion spring 678 to act upon the slide arms 674 andreturn the slide arms 674 to their initial position, wherein the firstend 680 of each of the slide arms 674 is positioned in the correspondingreceiving aperture 676 to be generally flush with the exterior surface684 of the piston stem 664. Subsequent proximal or rearward movement ofthe piston element 60 withdraws the piston stem 664 from the receivingcavity or bore 1340 in the plunger element 1302 and allows the plungerinterface element 654 to disengage from the plunger element 1302. Theplunger interface element 654 may be withdrawn into the front opening110 in the rear plate 102 of the pressure jacket support 100.Thereafter, the pressure jacket 136 may be pivoted upward to a removalorientation for removing the syringe 1120 and the syringe 1120 removedfrom the barrel 162 of the pressure jacket 136 according to theunloading procedure set forth previously in this disclosure.

A fourth syringe plunger 1300 and piston element 60 is discussedhereinafter with reference to FIGS. 47A-47I, wherein like elements areidentified with like reference numerals as used in the previouslydiscussed embodiments of the interfacing arrangements between thesyringe plunger 1300 and piston element 60. In the present embodiment, asliding key arrangement is used to form the mechanical interface betweenthe syringe plunger 1300 and piston element 60. In this embodiment, theplunger element 1302 is again a hollow element defining a receivingcavity or bore 1340. As with the rotational piston interfacingarrangement discussed previously, the rear flange portion 1312 comprisesan inward extending rib or rim 1342 at a proximal end for interfacingwith the piston element 60.

Opposing piston element 60 in the present embodiment comprises an outersleeve 692 as in previous embodiments and comprises a plunger interfaceelement 694 that is supported to a distal end of the outer sleeve 692.The plunger interface element 694 may be fixed to the distal end of theouter sleeve 692 by any suitable joining method including mechanicalfastening, friction fit engagement, or possibly via use of an adhesive.A proximal end 696 of the plunger interface element 694 seats against aninternal shoulder 698 defined within the outer sleeve 692. The plungerinterface element 694 comprises an outward extending radial flange 700seated against a distal end of the outer sleeve 692. The outer sleeve692 defines an internal compartment or cavity 702 which is enclosed bythe plunger interface element 694 and which houses a linear solenoid710. Linear solenoid 710 may be secured within the sleeve compartment702 via mechanical fastening, friction fit engagement, or possibly viause of an adhesive, and outer sleeve 692 defines a second, proximallylocated shoulder 704 in the sleeve compartment 702 against which thelinear solenoid 710 seats or engages to maintain the positioning of thelinear solenoid 710 in the sleeve compartment 702. The linear solenoid710 comprises an energizing portion 712 with a proximal flange 714 thatis seated against the second shoulder 704. The energizing portion 712defines a central bore or cavity 716 wherein an extendable andretractable solenoid output shaft 722 is coaxially disposed. Extendableand retractable solenoid output shaft 722 has a distal interface portion724 of reduced diameter as illustrated. The energizing portion 712 ofthe linear solenoid 710 is operable to extend and retract the solenoidoutput shaft 722 in a known manner in the electro-mechanical field ofendeavor.

The plunger interface element 694 comprises a piston stem 730 defining abore 732 enclosing a sliding key actuator 734 which is interfaced withthe distal interface portion 724 of the solenoid output shaft 722. Afixed connection is provided between the sliding key actuator 734 andthe distal interface portion 724 of the solenoid output shaft 722 sothat the extending and retracting movement of the solenoid output shaft722 is imparted directly to sliding key 740. The sliding key actuator734 is adapted to mechanically interface with a sliding key 740. Thesliding key actuator 734 comprises a plurality of distally extendingangled key elements 736 that define a plurality (typically a pair) ofangled slots 738 for interfacing with the sliding key 740. The slidingkey 740 comprises a pair of opposed key teeth 742, 744 each having aradial tip 745. The opposed key teeth 742, 744 are engaged by the distalkey elements 736 to effect radial movement of the key teeth 742, 744from a first or retracted position wherein the key teeth 742, 744 aredisposed within respective openings 746, 748 defined in the piston stem730 so as to be generally flush with an outer surface 750 of the pistonstem 730 of the plunger interface element 694, and an extended radialposition wherein the key teeth 742, 744 extend radially outward from therespective openings 746, 748 to interface with the radial rib or rim1342 formed on the rear flange portion 1312 of the plunger element 1302in the present embodiment. Each key tooth 742, 744 defines an opening751 for passage of one of the key elements 736 therethrough.

Referring in particular to FIG. 47A, this figure shows the pressurejacket 136 pivoted to a horizontal orientation and the syringe 1120loaded therein ready for interfacing with piston element 60.Accordingly, the loading steps for loading the syringe 1120 into thepressure jacket 136 are omitted in FIGS. 47A-47I, but follow the samemethodology as described previously in this disclosure. In FIG. 47A, thepiston stem 730 is spaced proximally from the syringe plunger 1300 andproximal of the rear flange portion 1312 of the plunger element 1302 ofthe syringe plunger 1300 but generally aligned with the receiving cavityor bore 1340 in the plunger element 1302. In the present embodiment, theorientation of syringe plunger 1300 is also not a concern as the keyteeth 742, 744 are operable to engage any portion of circumferentialproximal rib or rim 1342 formed on the rear flange portion 1312 of theplunger element 1302. Distal or forward movement of piston element 60allows the piston stem 730 to enter the receiving cavity or bore 1340 inthe plunger element 1302. As will be appreciated, an outer diameter ofthe piston stem 730 is less than an inner diameter of the interfacingradial rib or rim 1342 formed on the rear flange portion 1312 of theplunger element 1302. Accordingly, distal or forward motion of thepiston element 60 causes the piston stem 730 to enter the receivingcavity or bore 1340 until a distal tip or end 752 of the piston stem 730contacts or is in close proximity with the plunger cover 1304. At thislocation, the opposed openings 746, 748 in the piston stem 730 arelocated distally forward of the radial rim 1342 and coextensive with theannular recess 1344. Moreover, with the piston stem 730 extending intothe receiving cavity or bore 1340 in the plunger element 1302 any distalor forward motion of the piston element 60 automatically imparts distalor forward motion to the syringe plunger 1300 by contact engagementbetween the radial flange 700 on the plunger interface element 694 andthe rear flange portion 1312 of the plunger element 1302.

In FIGS. 47A-47D, the energizing portion 712 of the linear solenoid 710is in an energized state so that the solenoid output shaft 722 extendsdistally from the energizing portion 712 of the linear solenoid 710. Inthis state, the proximal end 726 of the solenoid output shaft 722defines a proximal open space 754 within the bore 716 of the energizingportion 712. In this distally extending position, the opposed key teeth742, 744 of the sliding key 740 are engaged in the angled slots 738defined by the distal key elements 736 whereby the key teeth 742, 744are retracted within the respective openings 746, 748 defined in thepiston stem 730 and generally flush with the outer surface 750 of thepiston stem 730 of the plunger interface element 694. This retractedorientation permits the piston stem 730 clear entry into the receivingcavity or bore 1340 in the plunger element 1302 of the syringe plunger1300 and allows passage through the inner diameter of the radial rib orrim 1342 on the rear flange portion 1312 of the plunger element 1302.

Referring in particular to FIGS. 47E-47G, as with certain previousembodiments, to cause proximal or rearward movement of the syringeplunger 1300 in the syringe body 1122 of the syringe 1120, aninterference engagement between the syringe plunger 1300 and pistonelement 60 is required. To form the interference engagement between thesyringe plunger 1300 and piston element 60, the energizing portion 712of linear solenoid 710 is de-energized whereby the solenoid output shaft722 retracts within the bore 716 of the energizing portion 712. As aresult of this proximal or rearward movement of the solenoid outputshaft 722, the proximal open space 754 in the bore 716 of the energizingportion 712 disappears. Further, as the solenoid output shaft 722withdraws into the energizing portion 712, the sliding key actuator 734moves proximally due to its fixed engagement with the distal interfaceportion 724 of the solenoid output shaft 722. Additionally, thisproximal movement causes the key teeth 742, 744 to move radially outwardas the key teeth 742, 744 are under the influence of the angled slots738 defined by the distal key elements 736. More particularly, as thekey actuator 734 moves proximally with the solenoid output shaft 722,the key teeth 742, 744 slide within their respective angled receivingslots 738 which, as illustrated, diverge outward from one another andthis divergent or angled orientation imparts radial outward movement tothe key teeth 742, 744. As the key teeth 742, 744 reach the opening ofthe slots 738, the radial tip 745 of each of the key teeth 742, 744seats within the annular recess 1344 defined by the proximal radial rim1342 on the rear flange portion 1312 of the plunger element 1302. Theinterference engagement between the key teeth 742, 744 and the radialrim 1342 is established immediately after the piston stem 664 fullyenters the receiving bore 1340 and either contacts or comes into closeproximity to the plunger cover 1304. Alternatively, the interferenceengagement may be established when the piston element 60 is directed tomove in the reverse or proximal direction by the electronic controldevice(s) associated with the injector 20. With the requisiteinterference engagement established between the key teeth 742, 744 andthe radial rim 1342 provided on the rear flange portion 1312, proximalor rearward movement of the piston element 60 causes the syringe plunger1300 to withdraw or move proximally or rearward in the syringe body 1122of the syringe 1120.

When it is desired to release the interference engagement between thesyringe plunger 1300 and piston element 60, the syringe plunger 1300 isdesirably first returned to the storage position by the piston element60 which corresponds to placement of the syringe plunger 1300 in thestorage/expansion section 1138 of the syringe body 1122 of the syringe1120 as described previously. The linear solenoid 710 is thenreenergized which moves the solenoid output shaft 722 distally orforward within the bore 716 of the energizing portion 712, therebyreestablishing a proximal space 954 within the bore 716 of theenergizing portion 712. This forward or distal movement is imparted tothe sliding key actuator 734 and results in the sliding key teeth 742,744 tracking into their respective angled slots 738 defined by thedistal key elements 736. As will be apparent, as the sliding key teeth742, 744 track in their respective angled slots 738, the key teeth 742,744 are radially withdrawn into the respective openings 746, 748 in thepiston stem 730. Once withdrawn to be flush with the outer surface 750of the piston stem 730, the piston stem 730 may be withdrawn from thereceiving cavity or bore 1340 defined in the plunger element 1302 by therearward movement of the piston element 60. When the plunger interfaceelement 694 disengages from the plunger element 1302, further proximalor rearward movement of the plunger interface element 694 withdraws itinto the front opening 110 in the rear plate 102 of the pressure jacketsupport 100. Thereafter, the pressure jacket 136 may be pivoted upwardto a removal orientation for removing the syringe 1120 from the barrel162 of the pressure jacket 136 according to the unloading procedure setforth previously in this disclosure.

A final syringe plunger 1300 and piston element 60 interfacingarrangement is discussed hereinafter with reference to FIGS. 48A-48D,wherein like elements are identified with like reference numerals asused in the previous embodiments of the interfacing arrangements betweenthe syringe plunger 1300 and piston element 60. In FIGS. 48A-48D, anattachment arm arrangement is used to form the mechanical interfacebetween the syringe plunger 1300 and piston element 60. In thisembodiment, plunger element 1302 is now a substantially solid elementthat has a proximal tab or button element 1356 extending proximally fromthe rear flange portion 1312 for engagement by the flexible support armarrangement as described herein. The proximal tab or button element 1356defines a circumferential recess 1358 which is engaged by the flexiblesupport arm arrangement as described herein.

Opposing piston element 60 in the present embodiment comprises a ballscrew shaft 770 disposed within an outer sleeve 772 and, as in previousembodiments, comprises a plunger interface element 774. The plungerinterface element 774 comprises a pair of flexible attachment arms 776that are fixed via pins 778 to the outer sleeve 772. The attachment arms776 are biased inward toward one another and toward a centrallongitudinal axis of the ball screw shaft 770 and further compriseinward directed radial tips 780. A wedge 782 is fixed to a distal end784 of the ball screw shaft 770 via a mechanical fastener 786. The wedge782 is adapted to effect operation of the attachment arms 776 asdescribed herein. Generally, the attachment arms 776 are maintained in aseparated orientation and generally parallel to one another as shown inFIGS. 48A and 48B by the interspacing of the wedge 782 between theattachment arms 776. As the ball screw shaft 770 rotates in onedirection, the outer sleeve 772 moves distally or proximally as iswell-known in the powered medical injector field. As the outer sleeve772 moves distally or forward, the attached attachment arms 776 likewisemove distally or forward relative to the wedge 782 and this movementeventually removes the separating force exerted on the attachment arms776 provided by the wedge 782. When this force is removed, theattachment arms 776 are permitted to move toward one another to engagethe proximal tab or button element 1356 extending proximally from therear flange portion 1312 of the plunger element 1302.

Referring in particular to FIG. 48A, this figure shows the pressurejacket 136 pivoted to a horizontal orientation and the syringe 1120loaded therein ready for interfacing with piston element 60.Accordingly, the loading steps for loading the syringe 1120 into thepressure jacket 136 are again omitted in FIGS. 48A-48D, but follow thesame methodology as described previously in this disclosure. As FIG. 48Ashows, the proximal tab or button element 1356 extending proximally fromthe rear flange portion 1312 of plunger element 1302 is spaced distallyfrom the attachment arms 776. As the ball screw shaft 770 rotates in onedirection, the outer sleeve 772 moves distally or forward due to athreaded connection between a ball screw nut (not shown) and the ballscrew shaft 770 and a fixed connection between the ball screw nut andthe outer sleeve 772 as is well-known in the powered medical injectorfield. At some point, a distal end 788 of the outer sleeve 772 contactsthe rear flange portion 1312 of the plunger element 1302. Moreover, asthe outer sleeve 772 moves forward or distally so do the attachedattachment arms 776, which move distally or forward relative to thewedge 782. The axial length of the wedge 782 is desirably selected sothat a spacing S between the inward directed radial tips 780 of theattachment arms 776 is maintained substantially constant at least untilthe distal end 788 of the outer sleeve 772 contacts the rear flangeportion 1312 of the plunger element 1302 so that the proximal tab orbutton element 1356 may pass between the radial tips 780. In thisposition, namely, when the distal end 788 of the outer sleeve 772contacts the rear flange portion 1312 of the plunger element 1302, theradial tips 780 of the attachment arms 776 are generally aligned withthe circumferential recess 1358 defined by the proximal tab or buttonelement 1356. Further rotation of the ball screw shaft 770 causesfurther forward or distal movement of the outer sleeve 772 which impartsforward or distal movement to syringe plunger 1300 in the syringe body1122 of the syringe 1120 and simultaneously forward or distal movementof the attached attachment arms 776. As a result of the rotationalmovement of the ball screw shaft 770 and the corresponding forward ordistal movement of the outer sleeve 772 and attached attachment arms776, the radial spacing or separating force provided by the wedge 782against attachment arms 776 is eventually removed, allowing theinwardly-biased attachment arms 776 to capture the proximal tab orbutton element 1356 extending proximally from rear flange portion 1312of the plunger element 1302.

When the wedging action of the wedge 782 is removed, the radial tips 780of the attachment arms 776 engage the circumferential recess 1358defined by the proximal tab or button element 1356, and a fixedengagement is now present between the syringe plunger 1300 and thepiston element 60. Continued rotation of the ball screw shaft 770 causesadvancement of the syringe plunger 1300 within the syringe body 1122 ofthe syringe 1120 due to the contact engagement between the distal end788 of the outer sleeve 772 and the rear flange portion 1312 of theplunger element 1302 of syringe plunger 1300. Rotation of the ball screwshaft 770 in the opposite direction causes withdrawal of the syringeplunger 1300 within the syringe body 1122 of the syringe 1120 due to theinterference engagement between the radial tips 780 of the attachmentarms 776 and the circumferential recess 1358 defined by the proximal tabor button element 1356 extending from the rear flange portion 1312 ofthe plunger element 1302 of the syringe plunger 1300. When it is desiredto release the fixed engagement between the syringe plunger 1300 andpiston element 60, the syringe plunger 1300 is desirably withdrawn tothe storage position by the piston element 60 which corresponds toplacement of the syringe plunger 1300 in the storage/expansion section1138 of the syringe body 1122 of the syringe 1120 as describedpreviously. Continued rotation of the ball screw shaft 770 causes theattachment arms 776 to re-engage the wedge 782 and the wedge 782 beginsto reassert a wedging action against the attachment arms 776 toreestablish the spacing S between the inward directed radial tips 780 ofthe attachment arms 776 of sufficient size to allow the distal radialtips 780 to disengage from the proximal tab or button element 1356extending proximally from the rear flange portion 1312 of the plungerelement 1302. Accordingly, additional rotation of the ball screw shaft770 withdraws the piston element 60 from association with the syringeplunger 1300, and the proximal tab or button element 1356 extendingproximally from rear flange portion 1312 of plunger element 1302 isagain spaced distally from the attachment arms 776. Thereafter, thepressure jacket 136 may be pivoted upward to a removal orientation forremoving the syringe 1120 from the barrel 162 of the pressure jacket 136according to the unloading procedure set forth previously in thisdisclosure.

Referring to FIGS. 49-56, another embodiment of a multi-fluid medicalinjection/injector system 10 is shown and wherein like parts aredesignated with like reference numerals as designated previously in thisdisclosure. As the fluid injector system 10 shown in FIGS. 49-56 isgenerally similar to previous embodiments set forth in this disclosureonly specific differences and/or modifications to the fluid injectorsystem 10 shown in FIGS. 49-56 are described herein. As describedpreviously, fluid injector system 10 comprises a powered injectoradministrator or device 20 and a fluid delivery set 1000 intended to beassociated with the injector 20 to conduct one or more fluids underpressure into a patient intravenously via a patient catheter. In thepresent embodiment, the injector 20 is illustrated with the embodimentof piston elements 60 described in connection with FIGS. 47A-47I. Thefluid delivery set 1000 in the present embodiment utilizes thesingle-use set 1500 described previously in this disclosure which isomitted from the various views for clarity purposes. Certainmodifications to the multi-use sets 1100 are present in the currentembodiment and such modifications are discussed in detail herein.

With respect to the pressure jacket support 100, the illustratedpressure jacket support 100 is substantially identical to that describedpreviously in this disclosure with the pressure jacket support 100having a rear plate 102 connected to the distal end 26 of the injectorhousing 22 of the injector 20 and a front plate 112, with the front andrear support plates 102, 112 connected by center beam 124. However, inthe present embodiment, the respective slots 122 in the front plate 112are located to be generally perpendicular to the central longitudinalaxis L of the syringe body 1122 of syringe 1120 when the syringe 1120 isloaded within the receiving pressure jacket 136 and the pressure jacket136 is in the generally horizontal position. Accordingly, the samepivotal movement of the pressure jacket 136, as described previously,automatically places the discharge conduit 1130 extending from thesyringe body 1122 of the syringe 1120 into the receiving slot 122 in thefront plate 112 of the pressure jacket support 100. As described herein,one difference in the present embodiment of the fluid injector system 10lies in the orientation of the discharge conduit 1130 of the syringebody 1122 which now lies along the central longitudinal axis L of thesyringe body 1122 of syringe 1120 rather than being offset therefrom aspreviously described in this disclosure. Therefore, as noted, therespective slots 122 in the front plate 112 of pressure jacket support100 are no longer offset to accommodate the offset discharge conduit1130 as described previously, but now are formed in the front plate 112to be generally perpendicular to the central longitudinal axis L of thesyringe body 1122 of syringe 1120 when the syringe 1120 is loaded withinthe receiving pressure jacket 136 and the pressure jacket 136 is in thegenerally horizontal position.

As discussed previously, the flange portion 142 and body portion 152 ofeach pressure jacket 136 may be separate components or be integrallyformed as a single or unitary body portion 152. This type of pressurejacket 136 is illustrated in FIGS. 49-56. Unitary body portion 152comprises all of the mounting features described previously inconnection with flange portion 142. Other than the foregoingdifferences, the various components of the pressure jacket support 100are the same as described previously in this disclosure.

Additionally, the fluid control module 200 in the present embodiment offluid injector system 10 incorporates certain modifications as nowdescribed hereinafter. Initially, it is noted that the fluid controlmodule housing 202 encloses and supports a pair of control valveactuators 220 within a depending enclosure 204 as described previously.However, the fluid control module housing 202 is now supported relativeto the front plate 112 of pressure jacket support 100 so that thedepending enclosure 204 locates the actuator output shaft 228 of eachcontrol valve actuator 220 on the rear or proximal side 116 of the frontplate 112 for interfacing with a control valve associated with thesyringe 1120 as described in detail herein. For this purpose, the frontplate 112 may comprise a bottom support flange 252 to which therespective control valve actuators 220 may be secured using mechanicalfasteners 254. A cover plate 206 encloses the depending enclosure 204 asdescribed previously.

Further, the fluid control module housing 202 in the present embodimentsupports a pair of top-mounted or top-located air detectors 260 tointerface with the input lines 1502, 1504 associated with the single-useset 1500. Additionally, the fluid control module housing 202 supports afront-mounted or front-located air detector 262 and a side-mounted orside-located air detector 264 to interface with the respectiveconnecting tubing 1174 to be associated with each syringe 1120 accordingto modifications to the syringe 1120 as described herein. The airdetectors 260, 262, 264 are generally similar in form and function tothe various air detectors described earlier in this disclosure. Withreference to the plan view of the fluid injector system 10 of FIG. 49,it is noted that the “top” syringe 1120 in this view will have itsassociated connecting tubing 1174 interfaced with the side-mounted airdetector 264 and the “lower” syringe 1120 in this view will have itsassociated connecting tubing 1174 interfaced with the front-mounted airdetector 262. Additionally, the front and side mounted air detectors262, 264 may comprise tubing attachment elements 268 in a similar mannerto tubing attachment elements described previously in this disclosure.

As discussed in the foregoing, the syringe 1120 adapted for use in thefluid injector system 10 according to the present embodiment ismodified, in one respect, so that the discharge conduit 1130 of thesyringe body 1122 which now lies along the central longitudinal axis Lof the syringe body 1122 of syringe 1120 rather than being offsettherefrom as previously described in this disclosure. Nonetheless, thesyringe 1120 comprises similar features to that described previously.Generally, syringe 1120 comprises an elongated, cylindrical syringe body1122 having a front or distal end 1124 and a rear or proximal end 1126.However, in the present embodiment of the syringe 1120, the distal end1124 of the syringe body 1122 comprises an outer skirt 1250 enclosing aconical-shaped distal portion or end 1252 and from which dischargeconduit 1130 extends distally. The conical-shaped distal portion or end1252 tapers inward at an angle of about 22.degree. in a similar mannerto the way the distal portion or end 1124 of the syringe body 1122tapers to the apex or cone point 1128 in the previously discussedembodiment of the syringe body 1122. The discharge conduit 1130 has adischarge port 1134 that is now coaxial with the central longitudinalaxis L of the syringe body 1122 and the discharge conduit 1130 may beformed with a conventional luer fitting-type connection to mate withadditional downstream components of the multi-use set 1100 adapted foruse with the present embodiment of the fluid injector system 10.

The proximal end 1126 of the syringe body 1122 may also be formed withan expansion/storage section 1138. A generally cylindrical “working”section 1140 of the syringe body 1122 connects the distal and proximalends 1124, 1126 of the syringe body 1122 and is defined essentiallyforward or distal of the expansion/storage section 1138 of the syringebody 1122. The cylindrical section 1140 of the syringe body 1122 has arelatively uniform outer diameter and the outer skirt 1250 extendsdistally from the cylindrical section 1140 of the syringe body 1122. Theouter skirt 1250 generally tapers inward slightly from the outerdiameter of the cylindrical section 1140 of the syringe body 1122. Theexpansion/storage section 1138 is provided generally as a storagesection or area for the syringe plunger 1300, as described previously.The proximal end 1126 of the syringe body 1122 is desirably formed withan outward extending lip 1142 (not shown in FIGS. 49-56) to providestrength and rigidity to the storage/expansion section 1138 of syringebody 1122 or provide other functions as also described previously.

The outer skirt 1250 further defines a pair of side openings 1254, 1256.The side openings 1254, 1256 are formed in the outer skirt 1250 to begenerally perpendicular to one another. As will be appreciated fromviewing FIG. 52, for example, side opening 1256 is actually intended asa “bottom” opening in the outer skirt 1250 to allow passage of theactuator output shaft 228 of the control valve actuator 220.Accordingly, it will be appreciated that loading of the syringe 1120into receiving pressure jacket 136 is orientation-specific and generallyrequires the syringe body 1122 to be oriented so that the side or bottomopening 1256 in outer skirt 1250 on the syringe body 1122 faces downwardin the pressure jacket 136. The interfacing tab or key elements 1144that mate with the keyway 158 in the body portion 152 of the pressurejacket 136 automatically orient the bottom opening 1256 into the correctorientation. Accordingly, as the pressure jacket 136 is pivoted to agenerally horizontal or working position with the syringe 1120 presenttherein, the side or bottom opening 1256 permits the actuator outputshaft 228 of the associated control valve actuator 220 to pass throughthe opening 1256. A distal edge 1258 of outer skirt 1250 desirablyexhibits an arcuate or curved shape and the receiving recesses 118 inthe rear or proximal side 116 of the front plate 112 are now desirablyformed with a mating arcuate or curved shape. This mating configurationprovides a similar self-centering function for the syringe 1120 whenpressurized as that described previously in this disclosure.

As with previously discussed embodiments, the multi-use sets 1100 foruse in the present embodiment comprise a fluid control valve 1150 and,particularly, a three-way stopcock valve 1160. Stopcock valve 1160 isgenerally similar to that described previously and comprises a valvebody 1161 defining three ports, 1162, 1164, and 1166 and a plug 1168actuated by an actuation handle 1170. In the present embodiment of thestopcock valve 1160, the actuation handle 1170 is disposed at the bottomend of the plug 1168 so as to be in a position to interface the actuatoroutput shaft 228 of the associated control valve actuator 220. The firstport 1162 is fluidly coupled to the discharge conduit 1130 on syringebody 1122 of syringe 1120 and this fluid coupling may be a permanentconnection by the methods described previously or, alternatively, adisconnecting connection may be provided between the first port 1162 andthe discharge conduit 1130 on the syringe body 1122. The second port1164 is fluidly coupled to a conventional connector spike 1175 viaconnecting tubing 1174 as described previously in this disclosure butomitted in FIGS. 49-56 for clarity purposes. The third port 1166 isprovided with a fluid connector 1176 which again is affixed to the thirdport 1166 via any of the conventional permanent joining methodsdescribed in the foregoing or a disconnecting arrangement may beprovided as an alternative if desired. The fluid connector 1176 maycomprise a radial skirt 1260 which faces the outer skirt 1250 on thesyringe body 1122 to enclose an annular space 1262 around the dischargeconduit 1130 for sterility purposes. As described previously, due to thepressures generated during operation of the syringe 1120, a permanentand robust fluid connection between the third port 1166 and the fluidconnector 1176 and between the first port 1162 and the discharge conduit1130 on the syringe body 1122 of syringe 1120 is generally preferred inaccordance with this disclosure.

As described previously, each control valve actuator 220 is adapted toselectively position the stopcock actuation handle 1170 to achieve atleast three set positions of the stopcock valve 1160, namely: (1) aninject or open position, wherein the first port 1162 is in fluidconnection with the third or outlet port 1166; (2) a fill position,wherein the second port 1164 is in fluid connection with the first port1162 to allow filling of the syringe 1120 via the connector spike 1175and the connecting tubing 1174 associated with a fluid supply container36, 38; and (3) a closed or isolation position, wherein the first andsecond ports 1162 and 1164 are isolated from the third or outlet port1166.

The loading of syringes 1120 into the pressure jackets 136 of thepressure jacket support 100 is substantially identical to the proceduredescribed previously in this disclosure other than for the differencesnoted in the foregoing. In particular, when loading the syringe 1120into the pressure jacket 136 in the upward pivoted position of thepressure jacket 136, the bottom opening 1256 in the syringe skirt 1250generally faces downward so as to orient the actuation handle 1170disposed at the bottom end of the plug 1168 of the stopcock valve 1160in a position to directly interface the actuator output shaft 228 of theassociated control valve actuator 220. Accordingly, as the pressurejacket 136 is pivoted downward generally to a horizontal orientation inthe pressure jacket operating space 104, the actuator output shaft 228automatically engages the actuation handle 1170 to form the operativeengagement between the actuation handle 1170 and the control valveactuator 220. Additionally, as the pressure jacket 136 is pivoteddownward, the distal edge 1258 of the outer skirt 1250 matingly engageswith the corresponding arcuate or curved shape of the receiving recesses118 in the rear or proximal side 116 of the front plate 112. This matingconfiguration provides a similar self-centering function for the syringe1120 when pressurized as that described previously in this disclosure.

Referring next to FIGS. 57-59 and with continued reference to FIGS.49-56, the fluid injector system 10 according to the illustratedembodiment exhibits a different movement of the injector 20 as it movesfrom the syringe loading position or orientation to the fluid primingand air purge position and then to the inject position. As shown inFIGS. 58A-58C, the injector 20 is supported by a pedestal support 900comprised of a support column 902 which may have a lower end 904 adaptedto interface with a patient supporting surface such as an examinationtable. The injector housing 22 is pivotally supported to the supportcolumn 902 via pivot pin 906. Additionally, a conventional IV pole 908is pivotally connected to the fluid control module housing 202 via apivot pin 910. A link arm 912 has a first end 914 and a second end 916.First end 914 of link arm 912 is pivotally connected to the supportcolumn 902 via a pivot pin 918 and the second end 916 of the link arm912 is pivotally connected via a pivot pin 920 to a lower end 922 of IVpole 908. The foregoing configuration defines a four bar linkagearrangement wherein the support column 902 defines the ground link, theinjector housing 22 defines one grounded link, the link arm 912 definesthe second grounded link, and the IV pole defines the coupler link as iswell-known the field of kinematics.

In the present embodiment of the fluid injector system 10, associationof the respective multi-use sets 1100 used with the injector 20 issubstantially similar to that described previously and generallycomprises inserting the respective syringes 1120 into the correspondingpressure jackets 136 according to the loading steps describedpreviously. However, as FIG. 57A demonstrates, while the injector 20 isstill in a horizontal orientation for loading syringe 1120 into thepressure jackets 136 in the present embodiment, the injector 20 isoriented on its side (e.g., one lateral side 24) so that the pressurejackets 136 are disposed one above the other. Accordingly, to load therespective pressure jackets 136 in the manner described previously inthis disclosure requires that the pressure jackets 136 pivot laterallyoutward from the injector 20, rather than pivot upward relative to theinjector 20 as described previously. Nonetheless, the loading steps setforth previously for loading the syringes 1120 into the respectivepressure jackets 136 result in the discharge outlet 1130 extendingdistally from the syringe body 1122 of each syringe 1120 being seatedinto the corresponding slot 122 defined in the front plate 112 of thepressure jacket support 100. Now, however, the arcuate distal edge 1258of the outer skirt 1250 on each syringe body 1122 engages the matingarcuate or curved shape of the receiving recesses 118 in the rear orproximal side 116 of the front plate 112 of the pressure jacket support100. Additionally, the pivoting movement of the pressure jackets 136 toreturn the pressure jackets 136 into their respective pressure jacketoperating spaces 104 defined by the pressure jacket support 100 resultsin the actuation handle 1170 disposed at the bottom end of the plug 1168for each stopcock valve 1160 being automatically mechanically interfacedwith the actuator output shaft 228 of the associated control valveactuator 220. With each pressure jacket 136 pivoted laterally into itspressure jacket operating space 104, each of the two multi-use sets 1100is ready for use. The association of the single-use set 1500 with therespective multi-use sets 1100 is the same as described previously inthis disclosure. Moreover, the details regarding associated the varioustubing elements associated with the multi-use sets 1100 with the frontand side mounted air detectors 262, 264 on the fluid control module 200are available in the foregoing description of these detectors. Once themulti-use sets 1100 have been installed and fluid supplies are connectedto the respective multi-use sets 1100 in the manner described previouslyin this disclosure, the electronic control device(s) associated withinjector 20 causes the piston elements 60 to drive the captured syringeplungers 1300 distally forward to contact and seat against theconically-tapered distal end 1124 of the syringe body 1122. Once theforegoing initial set-up sequence is completed, the injector 20 may bemoved to a fluid priming and air purge position as discussedhereinafter.

To reach the fluid priming and air purge position, the injector 20pivots about pivot pin 906 connecting the injector housing 22 to thesupport column 902. As this pivoting movement occurs, the link arm 912likewise pivots about pivot pin 918. IV pole 908 remains upright duringthe pivoting movement of the injector 20 and link arm 912 via the dualpivotal connections provided by pivot pins 910, 920. As the injector 20pivots to reach a generally vertical orientation, as shown in FIGS. 57C,58C, and 59C, the IV pole 908 and link arm 912 generally verticallyalign with the support column 902 along a generally vertical axis. Inthe vertical orientation of the injector 20, the syringes 1120 loaded inpressure jackets 136 are positioned vertically with the dischargeconduit 1130 extending from the syringe body 1122 of each syringe 1120loaded into the respective pressure jackets 136 pointed upward. With thesyringes 1120 positioned with the discharge conduit 1130 on each syringebody 1122 pointed upward, any air bubbles associated with the filling ofthe respective syringes 1120 with fluid will be present at the tapereddistal end 1124 of the syringe body 1122 of each syringe 1120 and in aposition for easy purging from the syringe body 1122. Once the injector20 is placed in the vertical position or orientation as illustrated, theattendant operator may press the “Fill/Purge” hard-wired button 34 onthe injector 20 to fill the respective syringes 1120 with fluid andpurge out air remaining in the syringe body 1122 of each syringe 1120.An exemplary automated sequence for the fluid priming and air purgecycle was described previously in this disclosure and is applicable tothe present embodiment of fluid injector system 10.

Once the fluid fill and air purge cycle is complete, the injector 20 isreturned to a horizontal orientation as shown in FIGS. 57A, 58A, and59A, and is again positioned on its side wherein the pressure jackets136 and syringes 1120 loaded therein are orientated one above the other.To reach this inject orientation, the injector 20 pivots about the pivotpin 906 connecting the injector housing 22 to the support column 902 butnow in the reverse direction. As this pivoting movement occurs, the linkarm 912 likewise pivots about pivot pin 918, again in the reversedirection. The IV pole 908 again remains upright during the pivotingmovement of the injector 20 and link arm 912 via the dual pivotalconnections provided by pivot pins 910, 920. As the injector 20 pivotsto reach a horizontal orientation on its side, the syringes 1120 loadedin the pressure jackets 136 are again positioned generally horizontalwith their discharge conduits 1130 pointed generally horizontally. It iswhen the injector 20 is rotated to the inject position that it isdesirable to connect the single-use set 1500 to the respective multi-usesets 1100 operatively associated with the injector 20 and, further,optionally interface the single-use set 1500 to the downstream orsecondary air detector module 360 (if present). Once the single-use set1500 is joined to the respective multi-use sets 1100, the single-use set1500 is primed with fluid and purged of air according to the exemplaryprocedure(s) described previously in this disclosure. When the fluidpriming and air purging procedure for the single-use set 1500 iscompleted, the injector 20 may be used in a fluid delivery procedure.Moreover, any of the refilling procedures described previously may beconducted using the fluid injector system 10 described in connectionwith FIGS. 49-59. Likewise the removing, storing, and reuse of a usedmulti-use set 1100 as described previously in this disclosure may beconducted using the present embodiment of the fluid injector system 10.Further, it is also noted that the foregoing four-bar linkage pivotingmotion of the injector 20 has distinct advantages in that the fluidsupply containers 36, 38 may again be kept close to the syringes 1120thereby decreasing the tubing lengths between the fluid supply container36, 38 and syringes 1120 and, as a result, decreasing the fill or refilltime for the syringes 1120.

The respective embodiments of the fluid injector system 10 set forth inthis disclosure can provide simultaneous flow of two fluids, forexample, contrast and saline in the foregoing embodiments at desiredpressures during a diagnostic or therapeutic procedure, such asangiography. Simultaneous flow can have significant clinical benefits toa patient having the procedure. These benefits include improved imagequality with less contrast dosing. The reduced contrast dosing is theresult of delivering contrast agent with a flushing agentsimultaneously. If excessive contrast can be reduced in this manner, itprovides patient benefits through reduced toxicity levels, and providesmore imaging options to patients with renal impairments. In anangiographic type procedure, for example, due to the fact that aclinician is observing the contrast in close proximity to the catheterwhere the fluid is delivered, phased delivery of such fluid would bereadily observable in the vasculature. This differs from a computedtomography (CT) application, where imaging is often performed after alevel of diffusion in the body.

Several fluid delivery techniques could be provided through thesimultaneous delivery of saline and contrast utilizing the fluidinjector systems 10 of this disclosure. One such fluid deliverytechnique is a pulse-type flow delivery. This would entail discretemotion of the piston elements 60. For example, one piston element 60 maymove a discrete distance allowing a specific volume of saline to beinjected into the patient; this could then be followed by a “pulse” ofcontrast initiated by the second piston element 60, then followed bysaline initiated by the initial “saline” piston element 60. This pulsingeffect may have clinical advantages in several areas. For example, inperipheral diagnostic applications, a discrete volume of contrast with agiven volume that opacifies the blood vessel over a given length couldbe grouped together in an alternating saline-contrast-saline delivery.This discrete contrast volume is then pushed down the peripheralvasculature by a significant volume of saline. Typically, 70-100 mlvolumes are used in such “run-off” type procedures. If this discretecontrast volume is synced with the movement of the imaging scannerthrough communication with the injector 20, a small volume of contrastcould be tracked to illuminate any restrictions or blockages and,thereby, significantly reduce the amount of contrast agent that must beinjected into the patient.

Additionally, through discrete coupled motion of the piston elements 60,saline flushing applications in diagnostics or therapeutics could have a“strobing” effect. This effect allows a discrete injection of saline tobe initiated by the saline side piston element 60 followed by a discreteinjection of contrast by the contrast side piston element 60, followedagain by another discrete injection of saline. It may be desirable tomake the discrete injections of saline to be a higher discrete volumethan the discrete volumes of contrast so that the total volume ofcontrast delivered is reduced. This quick pulse or “strobing” effectcould provide feedback information to the clinician during placement ofa stent, angioplasty, or other therapeutic approach, while reducing theamount of contrast delivered to the patient. The “strobing” effect couldbe configured for a time base or pattern.

While the foregoing pulsed flow delivery could be accomplished throughdiscrete motion of the piston elements 60, this effect could also bearrived at through operation of fluid control valves 1150 according toany of variations of the fluid control valves 1150 provided in thisdisclosure. However, this disclosure is not limited to the specificexamples provided in the foregoing and suitable “valving” for theseapplications could take the form of stopcocks, pinch valves, checkvalves, or other mechanisms that enable flow to be alternately enabledand shut-off from the saline side syringe 1120 and the contrast sidesyringe 1120. This type of flow switching could take many forms from avery rapid succession with small volumes to a much larger drawn outpulsing effect when several milliliters of volume of one fluid areinjected over several seconds then switched to the second fluid for ashort or long interval, and then back to the first fluid.

Further, in a steady state, simultaneous flow situation, when the pistonelements 60 are driven substantially simultaneously at a constant speed,adjusting the speed ratio of the piston elements 60 (e.g., saline pistonelement 60 speed to contrast piston element 60 speed) dynamically duringa fluid injection procedure has the effect of increasing the imageintensity or decreasing it as a function of time, volume, or usercontrol. In addition, operational control of the “valving” as describedin the foregoing paragraph provides the same effect as adjusting pistonelement speed.

To enable effective simultaneous flow delivery in fluid injector system10 according to the embodiments of this disclosure, substantially equalpressure must be present in each line input line 1502, 1504 of thesingle-use set 1500 along with an accounting for the capacitance in thesystem. Algorithms may be provided in the electronic control device(s)associated with the injector 20 to generally adjust for systemcapacitance and equalize pressure in the fluid injector system 10 so asto enable fluids from two fluid sources associated with fluid injectorsystem 10 to flow simultaneously. It is desirable to actuate the pistonelements 60 substantially simultaneously in simultaneous flow deliveryapplications to equalize the pressure in each line. If the injector 20is operated with differential pressure in each line input line 1502,1504 of the single-use set 1500, the fluid in the lower pressure linemay be stopped or reversed until sufficient capacitance is taken up inthat line and sufficient pressure is achieved to enable flow. This timedelay could reduce the usefulness of the image quality.

The foregoing multi-fluid injection techniques are desirable forreducing contrast dosing to a patient while providing effective imaging.By supplementing the overall fluid delivery procedure with saline,additional hydration of the patient occurs automatically and allows forflushing the renals enabling the body to remove the toxicity of thecontrast media. In addition to improved patient comfort level and lesstoxicity, introduction of saline at clinically significant pressures andflow rates also allows higher flow rates to be achieved at lowerpressure settings on the injector 20.

In another application, the embodiments of the fluid injector system 10of this disclosure may be applied to calculate the blood flow rate in anartery. To obtain blood flow rate in an artery, two measurements arerequired. The first measurement is the inside diameter (ID) of theartery and, second, the linear velocity of the contrast bolus within theartery. The flow rate can then be calculated using the simple formula:Q=AV, where Q is the flow rate, A is the area of the insidecross-sectional area of the artery, and V is the linear velocity of thecontrast bolus flow front. Measuring the artery inside diameter (ID) maybe done on a fluoroscope when the bolus of contrast fills the artery andis routinely done to measure stent sizes needed for an interventionalprocedure. The linear velocity of the contrast bolus can also bemeasured on the fluoroscope after the sharp contrast bolus is injectedby measuring the distance the flow front or bolus moves in a known timeperiod. Velocity can be calculated by the formula: V=D/T, where V is thelinear velocity, D is the distance the flow front of contrast traveled,and T is the unit of time that it takes for the flow front of contrastto travel the measured distance.

An important consideration in this method to obtain accurate flow rateinformation is delivering a tight, well defined contrast bolus in ashort period of time. This can be accomplished in several ways. Thecontrast bolus can be preceded and followed by a volume of saline thatis pre-positioned and primed into a tubing set. The injector 20 may thenbe triggered to deliver a high flow rate for a short period of time toflush the contrast bolus into the artery. The high instantaneous flowrate, in one example, can be accomplished by pre-pressurizing a syringebehind a closed valve, for example stopcock valve 1160, to remove allsystem compliance, and then opening the valve quickly for a short periodof time to deliver the contrast bolus. These injection steps can beautomated on the fluid injector system 10 via programming residing inthe electronic control device(s) associated with the injector 20 forease of use.

The single flow rate measurement described hereinabove only representsthe flow rate in the artery at a given moment in time. The actual flowrate in an artery varies depending on the heart cycle. The injector 20may be triggered based on the heart pulse to deliver the sharp contrastbolus at any desired point within the heart cycle to give maximum,minimum, or average flow rate measurements. Additionally the electroniccontrol device(s) associated with the injector 20 may be programmed togive a multiple pulsatile flow, injecting saline followed by contrastfollowed by saline repeatedly, as described previously. This multiplepulsatile flow allows multiple measurements to be obtained that wouldcharacterize the artery flow rate for the complete heart cycle.

The actual measurements taken to obtain the flow rates as describedabove can be automated by either incorporating the measurement functionsinto the imaging scanner hardware and software or by employing aseparate vision system looking at the display fluoroscope. The visionsystem could automatically measure the artery diameter, distance travelper unit time, and then perform the desired flow rate calculationautomatically and display the results graphically for the clinician.This foregoing application represents a novel use of the injector 20 formeasurement of blood flow rate using small volume pulsed contrastinjections.

In another feature of fluid injector system 10 according to theembodiments of this disclosure, it is known that when simultaneous flowfrom two syringes is joined together in a “Y” joint or similarconnection, both syringes encounter the same average pressure. In thepresent fluid injector system 10, syringes 1120 encounter this situationdue to the presence of Y-connector 1508 in the single-use set 1500. Thisaverage pressure causes both syringes 1120 to swell or have extracapacitance. The capacitance swelling is a function of the averagepressure, syringe material, syringe shape, and plunger design.

If one of the piston elements 60 pushing fluid in a syringe 1120 issignificantly faster than the other, for example two to three timesfaster, the slower piston element 60-syringe 1120 combination has afaster growing capacitance or volume than the volume being taken up bythe syringe plunger 1300 moving forward in the slower piston element60-syringe 1120 combination. In this situation, fluid in the tubing line(e.g., either input line 1502 or input line 1504) from the faster pistonelement 60-syringe 1120 combination will be pushed into the tubing linethat leads to the slower piston element 60-syringe 1120 combination,thereby exhibiting a reverse flow situation.

This reverse flow situation can be present in any two-syringe injectorsystems. The amount of back or reverse flow increases when the relativespeed difference is large, the simultaneous fluid flow is through asmall restriction, the speed of the total fluid injection is large, andthe viscosity of the fluid is high. The back or reverse flow can preventdifferent ratios of simultaneously delivered fluid from ever occurringin certain injections, which can be a detriment for all two-syringe typeinjector systems. A solution to this problem is to speed up the slowermoving piston element 60 in the fluid injector system 10 in proportionto the capacitive swelling that is occurring. Thus, the ratio ofsimultaneous fluid delivery can be maintained. The capacitance algorithmto accomplish this result first calculates the capacitive swelling as afunction of pressure (P) for the fluid delivery set 1000 used in thefluid injector system 10, which can be represented as follows: Cap(P)=volume in milliliters. This function can be derived from empiricaltesting or derived from material and shape calculations of the fluiddelivery set 1000. In the simplest case, it can be represented by alinear function. The capacitance algorithm then samples pressure at settime intervals and calculates the capacitance at this rate. At eachsample measurement, the change in capacitance is calculated and dividedby the sample rate time: Speed Up Flow={Cap(P(t1))−Cap(P(t2))}/Ts. Theforegoing approach is advantageous because it can be done with justknowledge of the pressure in the syringe 1120 and knowledge about thecharacteristics of the fluid delivery set 1000.

Use of test injections can further allow for determination of a pressuredrop across the fluid delivery set 1000 prior to entering a catheter. Inthis application, a series of either one continuous or multiple smalltest injections without a catheter connected to the catheter connectorconduit 1514 may be conducted by the electronic control device(s)associated with the injector 20. These injections are preprogrammed,using slow rise times so as to obtain accurate pressure measurements ofthe fluid delivery set 1000. A prediction of the pressure loss over thefluid delivery set 1000 is generated by the electronic control device(s)associated with injector 20 for any flow rate. It is known that poweredfluid injector systems typically use a variety of sensing mechanisms todetermine pressure within a syringe and such sensing mechanisms aredesirably part of the injector 20 in the present fluid injector system10. Using the predicted pressure loss, electronic control device(s)associated with the injector 20 can calibrate the pressure offset at theend of the single-use set 1500 and effectively subtract the lossesgenerated by the internal restriction pressure drops throughout thelength of the fluid delivery set 1000. This pressure loss calculationallows the pressure at the catheter inlet to be established at the ratedcatheter pressure, thus enabling increased flow. This pressure losspredication can then be displayed on the graphical user interface (GUI)display windows 32 on the injector housing 22, or other associatedGUI's. Additionally, control parameters may be preprogrammed based onthe maximum fluid delivery possibility and this feature would provideclinicians a derived fluid injection profile and provide them with anenhanced range of fluid delivery.

In another feature of the fluid injector system 10, during asimultaneous flow application, the volume of the fluid in the fluiddelivery set 1000 and the catheter connected thereto has a given ratioof fluids, typically saline and contrast, based on the last injectionparameters. Further, it is often desirable to determine desired optimalfluid ratios of saline and contrast for upcoming injections. However, asnoted, a fluid ratio may already be present in the fluid delivery set1000 and the connected catheter, and this previous fluid mixture must beflushed from the fluid delivery set 1000 and the connected catheter soas to not contaminate the new desired fluid ratio. Another algorithmresiding in the electronic control device(s) associated with theinjector 20 makes use of the geometry of the fluid delivery set 1000 andconnected catheter to adequately flush these elements to prepare for anew fluid ratio in an automated manner and have this new fluid ratioavailable at the catheter tip. As a result, simultaneous flowapplications using the fluid injector system 10 have increasedeffectiveness particularly in cardiology procedures.

While the foregoing discussion of the various embodiments of the fluidinjector system 10 was directed to the use of a dual syringe arrangementfor the delivery of two fluids such as contrast and saline, thisarrangement should not be considered limiting as revealed by FIGS.60-62, wherein a fluid injector system 10 comprising a multi-syringe1120 arrangement is shown. This embodiment comprises the same componentsas the embodiment of fluid injector system 10 shown in, for example,FIGS. 1-3 but adds an additional syringe 1120-pressure jacket 136combination or stage to the dual fluid injector system 10 describedpreviously. As the previous discussion regarding the fluid injectorsystem 10 generally shown in FIGS. 1-3 et seq. is applicable to theembodiment shown in FIGS. 60-62, only the relevant differences betweenthese systems are discussed hereinafter.

In FIGS. 60-62, for illustrative purposes, two of the syringes 1120 areshown in fluid connection with fluid supply container 38 via connectingtubing line 1174 which terminates in a conventional end connector spike1175. In particular, connecting tubing line 1174 further comprises abranch line 1174 a which connects to the second port 1164 on thestopcock valve 1160 associated with the upper most syringe 1120 in theviews shown in FIGS. 60-62 to provide fluid to this syringe 1120 fromfluid supply container 38. The upper most syringe 1120 comprises anultimate fluid connection with Y-connector 1508 via a third input line1504 a in the single-use set 1500 which is modified to include aY-connector 1508 that can accommodate such a third input line 1504 a.The association between the upper most syringe 1120 and the single-useset 1500 mirrors that described previously in this disclosure inconnection with the two lower syringes shown in the views of FIGS.60-62. The two lower syringes 1120 in the views shown in FIGS. 60-62otherwise have identical fluid connections as to the dual syringearrangement shown in FIGS. 1-3 et seq. Accordingly, it will be apparentthat the upper most syringe 1120 and the middle syringe 1120 in FIGS.60-62 are connected to the same fluid source, for example, a source ofsaline present in fluid supply container 38. As both of the foregoingupper and middle syringes 1120 are available to access a saline source,staggered or alternate operation of these syringes 1120 allows theclinician to have a continuous supply of saline, in the presentinstance, available for contrast flushing operations or other operationsinvolving the use of saline, with such operations only limited by thefluid available in fluid supply container 38. As a result, a continuousflow of fluid from the upper and middle syringes 1120 may be availableduring operation of the fluid injector system 10 shown in FIGS. 60-62only limited by the fluid available in fluid supply container 38.

While the foregoing illustrative example has two syringes 1120 coupledto a single fluid source, a distinct or separate fluid source may bededicated to the uppermost syringe 1120 in FIGS. 60-62 and, thus, thedepicted fluid injector system 10 would then be capable of delivering amixture of three different fluids to the single-use set 1500 (e.g.,simultaneous delivery in any desired mixture ratio), or sequentialdelivery of each of the three different fluids in any order desired withappropriate programming of the electronic control device(s) associatedwith the injector 20. Moreover, based on the foregoing concepts, it ispossible to add additional “stages” of syringe-pressure jacketcombinations to allow for the handling of additional fluids of differentor like kinds. In these multi-stage embodiments, the syringes 1120 maybe individually associated with individual fluid sources such as is thecase with the lowermost syringe 1120 shown in FIGS. 60-62, or two ormore syringes 1120 may each have a connection to a common fluid sourcesuch as is the case with the two upper syringes 1120 shown in FIGS.60-62; any combination of single-fluid source syringes 1120 or multiplesyringes 1120 drawing from the same fluid source may be provided in theforegoing multi-stage embodiments.

Further, the foregoing discussion relating to FIGS. 33-37 described thesequential movement of the injector 20 as it pivots from the fluidpriming and air purge orientation shown in FIG. 33 to the injectorientation shown in FIG. 37. As noted in this discussion, to reach theinjection position, the pivoting movement of injector 20 results in theinjector 20 “rolling” and traversing approximately 180.degree. ofrotation to pivot from the fluid priming and air purge orientation tothe inject orientation Likewise, the discussion relating to FIGS. 57-59described movement of the injector 20 from a generally horizontalorientation to a generally vertical fluid fill and air purge orientationand then a return to the generally horizontal orientation wherein thepressure jackets 136 and syringes 1120 are orientated generallyhorizontally and ready for an injection procedure. While such “global”movement of the injector 20 has numerous advantages, as an alternative,FIGS. 63-65 illustrate the fluid injector system 10 of FIGS. 1-3 et seq.wherein only the syringes 1120 are rotated between the fluid priming andair purge orientation (e.g., wherein the discharge outlet or conduit1130 is located at the “top”) and the inject orientation (e.g., whereinthe discharge outlet or conduit 1130 is located at the “bottom”). FIGS.63-65 illustrate that the slots 122 defined vertically in front plate112 may have a curved extension 122 a in the form of a generallysemicircular arc to accommodate rotational movement of the syringe 1120in the associated pressure jacket 136 so that the discharge outlet orconduit 1130 may be rotationally moved between the fluid priming and airpurge “top” orientation and the inject “bottom” orientation.

Numerous methods may be applied to obtain the desired rotationalmovement of the syringe 1120 in the associated pressure jacket 136. Forexample, the piston element 60 that captures the plunger 1300 in thesyringe 1120 may be adapted for rotational movement which is imparted tothe plunger 1300 via frictional contact between the plunger cover 1304and the interior wall of the syringe body 1122 of the syringe 1120; thisfrictional contact is desirably sufficient to effect the rotation of thesyringe 1120 in the pressure jacket 136 without “slippage” between theplunger 1300 and syringe 1120. Alternatively, interfering engagementstructures may be provided between, for example, the plunger element1302 of the plunger 1300 and a corresponding interior element (notshown) extending radially-inward from the interior wall of the syringebody 1122 so that rotation of the plunger 1300 causes the structure onthe plunger element 1302 to engage the radial structure extending fromthe interior wall of the syringe body 1122 and thereby transfer therotational motion of the piston element 60 to the syringe body 1122.Another suitable rotating arrangement includes a direct mechanicalengagement of the syringe 1120 while seated within the pressure jacket136 to cause rotation of the syringe 1120 therein. One such mechanicalarrangement includes the use of a frictional wheel that extends througha bottom opening in the pressure jacket 136 to frictionally engage theexterior surface of the syringe body 1122. Accordingly, rotationalmovement of the friction wheel and the frictional contact thereof withthe exterior surface of the syringe body 1122 desirably rotates thesyringe 1120 in the pressure jacket 136 while the plunger 1300 in thesyringe 1120 remains stationary under a restraining force provided bythe associated piston element 60 of the injector 20. Alternatively, theplunger 1300 may be allowed to rotate at least to some degree (orentirely) with the syringe 1120 by a suitable mechanical connection tothe associated piston element 60. The foregoing friction wheelarrangement may be supported by the center beam 124 connecting thesupport plates 102, 112 and include suitable electro-mechanism driveelements to effect rotation of the friction wheel and, further, includesuitable mechanical structure to allow the friction wheel to move intoand out of engagement within the bottom opening in the pressure jacket136 so as not to impede the loading and unloading of the pressure jacket136. As an alternative, the friction wheel may have gear teeth and likestructures for interfacing with suitable profiling on/in the surface ofthe syringe body 1122 of the syringe 1120 to allow the gear teeth orprofiling on the friction wheel to engage corresponding gear structuresor other profiling on the surface of the syringe body 1122 of thesyringe 1120 to cause the desired rotation of the syringe 1120 in thepressure jacket 136.

Another direct mechanical engagement arrangement for impartingrotational movement to the syringe 1120 includes a driven belt (or rope)arrangement wherein a frictional belt engages the syringe body 1122while positioned within the pressure jacket 136. Such a driven beltarrangement shares common characteristics with the foregoing drivenwheel arrangement and may be driven in either direction to effectmovement of the syringe 1120 in the pressure jacket 136 in eitherrotational direction. In each of the foregoing arrangements foreffecting rotation of the syringe 1120 in the pressure jacket 136, it isdesirable for the intermediate conduit element 1172 to have sufficientlength and flexibility to accommodate the rotational movement of thesyringe 1120 in the pressure jacket 136. As a reminder, the conduitelement 1172 is bonded to the first port 1162 of the stopcock valve 1160and to the discharge conduit 1130 on the syringe body 1122 of thesyringe 1120 but is also present in other embodiments of the fluidcontrol valve 1150 for connecting the first port on the variousembodiments of the fluid control valve 1150 with the discharge conduit1130 on the syringe body 1122 of the syringe 1120.

Referring next to FIG. 66, the foregoing embodiments of the fluidinjector system 10 have additional applications in the medical fieldsuch as for non-invasive assessment of blood flow in a blood vessel. Inmany vascular procedures it is desirable to know the flow in a bloodvessel V to assess the significance of a stenosis, the suitability for atransplant, or possibly to assess the presence of microvascular diseasewhich cannot be detected any other way. Using the foregoing fluidinjector system(s) 10, the system(s) 10 may be programmed for aninjection of diluted contrast into the blood vessel V through a catheterC with a long, for example, more than 1 second, linearly rising flowrate, and the resulting flow rate may be displayed real time on thefluoroscopy image of the procedure displayed on a suitable monitor. Anattending physician (or possibly a computer) can review the images andselect the one where reflux begins (e.g., the reflux point RP), and theflow in the blood vessel is approximately equal to the injection rate onthe image. This application is well-suited for a real timeinjector-imager communication interface, or the ability to post-processsynchronize the injections. It is desirable to use diluted contrastmedia so that its viscosity does not significantly affect the flow anddiluted contrast also reduces the contrast loading to the patient. Whilea real time injector interface to the imaging system and a displaymonitor are preferable, alternatively, before there is a real timeconnection between the injector and the imager, the injector could beenunciating the flow rates in, for example, 0.5 ml/sec increments, andwhen the physician identifies the reflux point RP on the displayedimage, he or she or another attendant person can record the last recitedflow rate or, when the reflux is identified, a clinician may touch oneof the display windows 32 on the injector 20 or one of the controlbuttons 34 on the injector 20 such as the “Acknowledge/Start” button,and the injector 20 saves the latest flow rate. The catheter C isdesirably a multi-opening catheter with side openings for accuracypurposes as a single end-opening catheter could exhibit a streaming offluid from the end opening which could affect measurements. Desirably,the selected catheter may have several lumens all the way to the tip sothat saline could be injected out of the side openings distally at thetip while contrast is injected from the more proximally-located sideopenings. The contrast flow rate is desirably relatively slow andconstant. The saline flow could ramp-up and, at the point where thecontrast starts to reflux, the contrast flow rate plus the saline flowrate equals the vessel natural flow rate. The injection may start at aflow rate other than zero, thereby bracketing the expected flow rate, orthe injection flow rate could start at zero if the expected flow is low.If images are acquired at, for example, 30 frames per second, theinjection only needs to last a few seconds to be reasonably accurate,subject to the need for some time to allow the fluid injector system 10to get up to speed and pressurize the system 10 to fill all themechanical capacitance of the system 10. Optionally, the physician mayselect an area of interest on the displayed image, and the injector 20can increase flow until contrast refluxes into the selected area. Thechange in flow rate does not have to be linearly rising and could bestepped, decreasing, or varying in some other way. In the case wherethere is automatic feedback, the injector 20 could start reasonably low,then jump high, and eventually identify the right flow rate.

While embodiments of a multi-fluid medical injector system and methodsof operation thereof were provided in the foregoing description, thoseskilled in the art may make modifications and alterations to theseembodiments without departing from the scope and spirit of theinvention. Accordingly, the foregoing description is intended to beillustrative rather than restrictive. The invention describedhereinabove is defined by the appended claims and all changes to theinvention that fall within the meaning and the range of equivalency ofthe claims are to be embraced within their scope.

The invention claimed is:
 1. An automatic refill procedure for a fluidinjector system comprising a fluid injector and an operably engagedsyringe, the procedure comprising: providing at least one handcontroller configured to operate at least a portion of the fluidinjector system; providing at least one sensor disposed in the at leastone hand controller, the at least one sensor comprising at least one ofthe following: an accelerometer, a position sensor, an orientationsensor, a capacitance touch sensor, a thermal sensor, or any combinationthereof; providing at least one processor in communication with thefluid injector system; determining, with the at least one processor, ifa fluid injection procedure involving the syringe is impending based atleast partially on inactivity of the at least one hand controller of thefluid injector system for a certain period of time, wherein theinactivity of the at least one hand controller for the certain period oftime is determined based at least partially on the at least one sensorin the at least one hand controller, and indicates that the fluidinjection procedure involving the syringe is not impending; andinitiating, with the at least one processor, an automatic refill of thesyringe in response to determining that the fluid injection procedureinvolving the syringe is not impending, such that the automatic refilldoes not interfere with an impending fluid injection procedure.
 2. Theautomatic refill procedure of claim 1, wherein the at least oneprocessor comprises a timer for monitoring the inactivity of the atleast one hand controller of the fluid injector system, and wherein theinactivity of the at least one hand controller for the certain period oftime indicates that the automatic refill of the syringe will notinterfere with the impending fluid injection procedure.
 3. The automaticrefill procedure of claim 1, wherein the at least one sensor in the atleast one hand controller signals to the at least one processor that theat least one hand controller is inactive.
 4. The automatic refillprocedure of claim 1, further comprising: determining if a preprogrammedtrigger minimum volume is present in the syringe.
 5. The automaticrefill procedure of claim 4, wherein the preprogrammed trigger minimumvolume is at least partially determined by or from at least one of thefollowing: tracking a fluid volume dispensed from the syringe duringoperation of the fluid injector system, a fluid level sensor associatedwith the syringe, an amount of fluid to perform a next fluid injectionprocedure, or any combination thereof.
 6. The automatic refill procedureof claim 4, wherein the preprogrammed trigger minimum volume isdetermined to be present in the syringe when, at the completion of afluid injection procedure, there is not enough fluid to perform a nextfluid injection procedure.
 7. The automatic refill procedure of claim 1,wherein the initiated automatic refill refills the syringe withoutinducing a vacuum condition in the syringe.
 8. A fluid injector systemcomprising a fluid injector and an operably engaged syringe, comprising:at least one hand controller configured to operate at least a portion ofthe fluid injector system; at least one sensor disposed in the at leastone hand controller, the at least one sensor comprising at least one ofthe following: an accelerometer, a position sensor, an orientationsensor, a capacitance touch sensor, a thermal sensor, or any combinationthereof; and at least one processor in communication with the fluidinjector system, the at least one processor configured to: determine ifat least one fluid injection procedure involving the syringe isimpending based at least partially on inactivity of the at least onehand controller of the fluid injector system for a certain period oftime, wherein the inactivity of the at least one hand controller for thecertain period of time is determined based at least partially on the atleast one sensor in the hand controller, and indicates that the fluidinjection procedure involving the syringe is not impending; and initiatean automatic refill of the syringe if the at least one fluid injectionprocedure is not determined to be impending, such that the automaticrefill of the syringe will not interfere with the fluid injectionprocedure.
 9. The fluid injector system of claim 8, wherein thedetermination if at least one fluid injection procedure involving thesyringe is impending is based at least partially on at least one of thefollowing: a movement of the at least one hand controller, anorientation of the at least one hand controller, a physical contactbetween the at least one hand controller and an individual, or anycombination thereof.